Trial Outcomes & Findings for Developing an Activity Pacing Framework: Feasibility and Acceptability (NCT NCT03497585)
NCT ID: NCT03497585
Last Updated: 2020-12-17
Results Overview
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
COMPLETED
112 participants
Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
2020-12-17
Participant Flow
For the feasibility study, patient recruitment occurred between 21st May 2018 and 3rd September 2019. Patients were recruited from those referred to a rehabilitation programme within a physiotherapy-led, out-patient service in a National Health Service (NHS) Trust in Northern England. The acceptability interviews involved patients (as above) and healthcare professionals (HCPs) delivering the programmes. HCP recruitment occurred between 18th September 2019 and 6th November 2019.
This was a single-arm feasibility study. All patients received the same treatment, that is, they all attended the same rehabilitation programme that was underpinned by the activity pacing framework. Excluded from the study were those patients who did not meet the inclusion/exclusion criteria.
Participant milestones
| Measure |
Activity Pacing Framework
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Overall Study
STARTED
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112
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Overall Study
COMPLETED
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57
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Overall Study
NOT COMPLETED
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55
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One missing answer
Baseline characteristics by cohort
| Measure |
Activity Pacing Framework
n=107 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Age, Continuous
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55.25 years
STANDARD_DEVIATION 12.83 • n=106 Participants • One missing answer
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Sex: Female, Male
Female
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92 Participants
n=107 Participants
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Sex: Female, Male
Male
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15 Participants
n=107 Participants
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Race/Ethnicity, Customized
Ethnicity · White (British, Irish, Other)
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99 Participants
n=106 Participants • One missing answer
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Race/Ethnicity, Customized
Ethnicity · Black (Caribbean, African)
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1 Participants
n=106 Participants • One missing answer
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Race/Ethnicity, Customized
Ethnicity · Mixed (White/Black, White/Asian, other)
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3 Participants
n=106 Participants • One missing answer
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Race/Ethnicity, Customized
Ethnicity · Asian (Indian, Pakistani, Bangladeshi, other)
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3 Participants
n=106 Participants • One missing answer
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Race/Ethnicity, Customized
Ethnicity · Asian Eastern (Chinese, other)
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0 Participants
n=106 Participants • One missing answer
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Conditions
Low back pain
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79 Participants
n=106 Participants • One participant gave a missing answer
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Conditions
Chronic widespread pain
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52 Participants
n=106 Participants • One participant gave a missing answer
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Conditions
Fibromyalgia
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29 Participants
n=106 Participants • One participant gave a missing answer
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Conditions
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
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12 Participants
n=106 Participants • One participant gave a missing answer
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Conditions
Other (e.g. osteoarthritis)
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21 Participants
n=106 Participants • One participant gave a missing answer
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Number of conditions
1 condition
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41 Participants
n=106 Participants • One missing answer
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|
Number of conditions
2 conditions
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49 Participants
n=106 Participants • One missing answer
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|
Number of conditions
3 conditions
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12 Participants
n=106 Participants • One missing answer
|
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Number of conditions
4 conditions
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2 Participants
n=106 Participants • One missing answer
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Number of conditions
5 conditions
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2 Participants
n=106 Participants • One missing answer
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PRIMARY outcome
Timeframe: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programmePopulation: Of the 107 participants who commenced the rehabilitation programme and provided baseline data (T1), 65 participants completed the data collection at the end of the 6-week rehabilitation programme. There were two missing answers for APQ-28 Activity adjustment.
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Outcome measures
| Measure |
Activity Pacing Framework
n=65 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
APQ-28 Activity adjustment
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0.70 score on a scale
Interval 0.48 to 0.91
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Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
APQ-28 Activity planning
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0.99 score on a scale
Interval 0.72 to 1.26
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Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
APQ-28 Activity consistency
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0.84 score on a scale
Interval 0.6 to 1.07
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Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
APQ-28 Activity acceptance
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0.67 score on a scale
Interval 0.46 to 0.89
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Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
APQ-28 Activity progression
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0.94 score on a scale
Interval 0.65 to 1.22
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SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: Included in these analyses are all 107 participants who provided data at baseline. There is one missing answer for APQ-28 Activity adjustment
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Outcome measures
| Measure |
Activity Pacing Framework
n=107 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity adjustment
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1.83 score on a scale
Standard Deviation 0.81
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Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity planning
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1.49 score on a scale
Standard Deviation 0.98
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Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity consistency
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1.85 score on a scale
Standard Deviation 0.94
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Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity acceptance
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1.91 score on a scale
Standard Deviation 0.92
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Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity progression
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1.51 score on a scale
Standard Deviation 0.95
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SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: Of the 107 participants who completed baseline data (T1), 65 completed data collection at the end of the 6-week rehabilitation programme (T2). There were two missing answers for APQ-28 Activity adjustment.
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Outcome measures
| Measure |
Activity Pacing Framework
n=65 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity adjustment
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2.43 score on a scale
Standard Deviation 0.73
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Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity planning
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2.42 score on a scale
Standard Deviation 0.87
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Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity consistency
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2.65 score on a scale
Standard Deviation 0.74
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Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity acceptance
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2.55 score on a scale
Standard Deviation 0.72
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Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity progression
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2.39 score on a scale
Standard Deviation 0.89
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SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: Of the 107 participants who completed baseline data collection (T1) and those who completed the end of treatment (T2) data collection, 52 participants completed the 3-month follow-up data collection (T3). There were two missing answers for APQ Activity adjustment.
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Outcome measures
| Measure |
Activity Pacing Framework
n=52 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity adjustment
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2.33 score on a scale
Standard Deviation 0.90
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Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity planning
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2.06 score on a scale
Standard Deviation 1.02
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Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity consistency
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2.37 score on a scale
Standard Deviation 0.72
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Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity acceptance
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2.42 score on a scale
Standard Deviation 0.95
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Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
APQ-28 Activity progression
|
2.00 score on a scale
Standard Deviation 0.91
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SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: 107 participants completed the baseline questionnaire booklet. However, there was one missing answer for Current pain (n=106); and four missing answers for Usual pain (n=103).
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)
Outcome measures
| Measure |
Activity Pacing Framework
n=106 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Current pain
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6.71 score on a scale
Standard Deviation 1.96
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Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Usual pain
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7.47 score on a scale
Standard Deviation 1.69
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SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: All 65 participants completed the scales for current and usual pain in the 6-weeks (T2) questionnaire booklet. There were no missing answers
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.
Outcome measures
| Measure |
Activity Pacing Framework
n=65 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Current pain
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5.31 score on a scale
Standard Deviation 2.38
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Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Usual pain
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6.62 score on a scale
Standard Deviation 2.08
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SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: 52 participants completed the questionnaire booklets at 3-months follow-up. However, there were two missing answers for Usual pain.
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme
Outcome measures
| Measure |
Activity Pacing Framework
n=52 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Current pain
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5.65 score on a scale
Standard Deviation 2.31
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Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Usual pain
|
6.54 score on a scale
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: Three missing answers from the 107 participants at baseline (T1)
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Outcome measures
| Measure |
Activity Pacing Framework
n=104 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
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13.26 score on a scale
Standard Deviation 6.86
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SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: Two missing answers from the 65 participants at T2
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Outcome measures
| Measure |
Activity Pacing Framework
n=63 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
|
7.14 score on a scale
Standard Deviation 6.09
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SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: One missing answer from the 52 participants at T3.
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Outcome measures
| Measure |
Activity Pacing Framework
n=51 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
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Depression at 3-months Follow-up: Patient Health Questionnaire-9
|
9.09 score on a scale
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: One missing answer from the 107 participants at baseline (T1)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Outcome measures
| Measure |
Activity Pacing Framework
n=106 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
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|---|---|
|
Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
|
9.89 score on a scale
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: 65 participants at 6-weeks data collection (T2)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Outcome measures
| Measure |
Activity Pacing Framework
n=65 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
|
5.40 score on a scale
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: 52 participants provided data at 3-months (T3)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Outcome measures
| Measure |
Activity Pacing Framework
n=52 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
|
6.10 score on a scale
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: All 107 participants at T1 provided an answer
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Outcome measures
| Measure |
Activity Pacing Framework
n=107 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
|
25.67 score on a scale
Standard Deviation 11.93
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: All 65 participants at T2 provided an answer
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Outcome measures
| Measure |
Activity Pacing Framework
n=65 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
|
36.29 score on a scale
Standard Deviation 14.12
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: All 52 participants at 3-months follow-up (T3) provided an answer
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Outcome measures
| Measure |
Activity Pacing Framework
n=52 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
|
34.68 score on a scale
Standard Deviation 14.26
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: 107 participants completed the first questionnaire booklet (T1). However, there were four missing answers for physical fatigue (n=103) and one missing answer for mental fatigue (n-106)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Outcome measures
| Measure |
Activity Pacing Framework
n=106 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
Physical fatigue
|
14.81 score on a scale
Standard Deviation 4.54
|
|
Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
Mental fatigue
|
8.83 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: 65 participants completed the 6-weeks questionnaire booklet (T2). However, there were three missing answers on the Physical fatigue subscale (n=62) and one missing answer on the Mental fatigue scale (n=64).
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Outcome measures
| Measure |
Activity Pacing Framework
n=64 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
Physical fatigue
|
20.31 score on a scale
Standard Deviation 3.92
|
|
Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
Mental fatigue
|
11.28 score on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: Three missing answers for the Physical fatigue subscale; one missing answer for the Mental fatigue subscale
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Outcome measures
| Measure |
Activity Pacing Framework
n=51 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
Physical fatigue
|
18.18 score on a scale
Standard Deviation 4.16
|
|
Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
Mental fatigue
|
10.92 score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: One missing answer
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Outcome measures
| Measure |
Activity Pacing Framework
n=106 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
|
13.14 score on a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: One missing answer
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Outcome measures
| Measure |
Activity Pacing Framework
n=64 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
|
10.28 score on a scale
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: All 52 participants at 3-months follow-up (T3) provided an answer for this subscale.
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Outcome measures
| Measure |
Activity Pacing Framework
n=52 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
|
12.12 score on a scale
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: Two missing answers for the physical and mental function subscales
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Outcome measures
| Measure |
Activity Pacing Framework
n=105 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
Physical function
|
33.96 score on a scale
Standard Deviation 8.82
|
|
Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
Mental function
|
40.00 score on a scale
Standard Deviation 11.36
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: Two missing answers on the Physical and Mental function subscales
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Outcome measures
| Measure |
Activity Pacing Framework
n=63 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
Physical function
|
38.82 score on a scale
Standard Deviation 9.06
|
|
Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
Mental function
|
45.83 score on a scale
Standard Deviation 11.48
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: Five missing answers on the Physical and Mental function subscales
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Outcome measures
| Measure |
Activity Pacing Framework
n=47 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
Physical function
|
36.55 score on a scale
Standard Deviation 9.81
|
|
Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
Mental function
|
44.56 score on a scale
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment: up to one week before the programme)Population: Seven missing answers from the 107 participants at baseline (T1).
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
Activity Pacing Framework
n=100 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
|
0.42 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 6-weeks (end of the programme)Population: Six missing answers from the 65 participants at 6-weeks (T2) data collection
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
Activity Pacing Framework
n=59 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
|
0.56 score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 3-months follow-up (after the end of the 6-week's programme)Population: Seven missing answers from the 52 participants who responded to the 3-months follow-up (T3)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
Activity Pacing Framework
n=45 Participants
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
|
|---|---|
|
General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
|
0.52 score on a scale
Standard Deviation 0.29
|
Adverse Events
Activity Pacing Framework
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place