Trial Outcomes & Findings for The MSK-Tracker Study (NCT NCT03559205)
NCT ID: NCT03559205
Last Updated: 2021-11-10
Results Overview
A measure of patient empowerment. Scale: Much better / Much more = 2 Better / More = 1 Same or less = 0 Not applicable = 9
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
321 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-11-10
Participant Flow
Note 321 participants were enrolled but baseline data was only collected from 273.
Participant milestones
| Measure |
MSK-Tracker (Before)
Usual Care in clinic consultations
|
MSK-Tracker (After)
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
144
|
|
Overall Study
Baseline Data
|
141
|
132
|
|
Overall Study
COMPLETED
|
65
|
57
|
|
Overall Study
NOT COMPLETED
|
112
|
87
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
only working patients
Baseline characteristics by cohort
| Measure |
MSK-Tracker (Before)
n=141 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=132 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.73 years
STANDARD_DEVIATION 15.06 • n=141 Participants
|
51.91 years
STANDARD_DEVIATION 14.61 • n=132 Participants
|
53.88 years
STANDARD_DEVIATION 14.94 • n=273 Participants
|
|
Sex/Gender, Customized
Male
|
74 Participants
n=141 Participants
|
81 Participants
n=132 Participants
|
155 Participants
n=273 Participants
|
|
Sex/Gender, Customized
Female
|
67 Participants
n=141 Participants
|
50 Participants
n=132 Participants
|
117 Participants
n=273 Participants
|
|
Sex/Gender, Customized
Prefer not to say
|
0 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
1 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
2 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=141 Participants
|
2 Participants
n=132 Participants
|
5 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
2 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
White
|
133 Participants
n=141 Participants
|
126 Participants
n=132 Participants
|
259 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=141 Participants
|
2 Participants
n=132 Participants
|
3 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Prefer not to say
|
1 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
2 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=273 Participants
|
|
Pain Location(s)
Head region
|
3 Participants
n=141 Participants
|
3 Participants
n=132 Participants
|
6 Participants
n=273 Participants
|
|
Pain Location(s)
Neck
|
27 Participants
n=141 Participants
|
27 Participants
n=132 Participants
|
54 Participants
n=273 Participants
|
|
Pain Location(s)
Shoulder/upper arm
|
35 Participants
n=141 Participants
|
27 Participants
n=132 Participants
|
62 Participants
n=273 Participants
|
|
Pain Location(s)
Lower arm/wrist
|
16 Participants
n=141 Participants
|
11 Participants
n=132 Participants
|
27 Participants
n=273 Participants
|
|
Pain Location(s)
Hand(s)
|
14 Participants
n=141 Participants
|
19 Participants
n=132 Participants
|
33 Participants
n=273 Participants
|
|
Pain Location(s)
Upper back/chest/abdomen
|
13 Participants
n=141 Participants
|
14 Participants
n=132 Participants
|
27 Participants
n=273 Participants
|
|
Pain Location(s)
Lower back/pelvis
|
64 Participants
n=141 Participants
|
59 Participants
n=132 Participants
|
123 Participants
n=273 Participants
|
|
Pain Location(s)
Hip, groin, thigh
|
39 Participants
n=141 Participants
|
36 Participants
n=132 Participants
|
75 Participants
n=273 Participants
|
|
Pain Location(s)
Knee/lower leg
|
42 Participants
n=141 Participants
|
51 Participants
n=132 Participants
|
93 Participants
n=273 Participants
|
|
Pain Location(s)
Ankle/foot
|
22 Participants
n=141 Participants
|
28 Participants
n=132 Participants
|
50 Participants
n=273 Participants
|
|
Pain Location(s)
Other
|
12 Participants
n=141 Participants
|
9 Participants
n=132 Participants
|
21 Participants
n=273 Participants
|
|
Problem duration
< 2 weeks
|
0 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=273 Participants
|
|
Problem duration
2 to 4 weeks
|
6 Participants
n=141 Participants
|
2 Participants
n=132 Participants
|
8 Participants
n=273 Participants
|
|
Problem duration
5 weeks to 3 months
|
32 Participants
n=141 Participants
|
18 Participants
n=132 Participants
|
50 Participants
n=273 Participants
|
|
Problem duration
4 to 6 months
|
21 Participants
n=141 Participants
|
14 Participants
n=132 Participants
|
35 Participants
n=273 Participants
|
|
Problem duration
7 to 12 months
|
16 Participants
n=141 Participants
|
21 Participants
n=132 Participants
|
37 Participants
n=273 Participants
|
|
Problem duration
13 months to 3 years
|
35 Participants
n=141 Participants
|
30 Participants
n=132 Participants
|
65 Participants
n=273 Participants
|
|
Problem duration
> 3 years
|
30 Participants
n=141 Participants
|
46 Participants
n=132 Participants
|
76 Participants
n=273 Participants
|
|
Problem duration
Missing
|
1 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
2 Participants
n=273 Participants
|
|
Previous physio for problem
No
|
65 Participants
n=141 Participants
|
77 Participants
n=132 Participants
|
142 Participants
n=273 Participants
|
|
Previous physio for problem
Yes
|
76 Participants
n=141 Participants
|
55 Participants
n=132 Participants
|
131 Participants
n=273 Participants
|
|
Previous surgery for problem
No related surgery
|
124 Participants
n=141 Participants
|
116 Participants
n=132 Participants
|
240 Participants
n=273 Participants
|
|
Previous surgery for problem
1 related surgery
|
11 Participants
n=141 Participants
|
8 Participants
n=132 Participants
|
19 Participants
n=273 Participants
|
|
Previous surgery for problem
2 related surgeries
|
3 Participants
n=141 Participants
|
4 Participants
n=132 Participants
|
7 Participants
n=273 Participants
|
|
Previous surgery for problem
3 or more related surgeries
|
3 Participants
n=141 Participants
|
4 Participants
n=132 Participants
|
7 Participants
n=273 Participants
|
|
Previous surgery for problem
Missing
|
0 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=273 Participants
|
|
Referral source
GP
|
130 Participants
n=141 Participants
|
126 Participants
n=132 Participants
|
256 Participants
n=273 Participants
|
|
Referral source
Self-referral
|
0 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
1 Participants
n=273 Participants
|
|
Referral source
Orthopaedic Surgeon
|
7 Participants
n=141 Participants
|
1 Participants
n=132 Participants
|
8 Participants
n=273 Participants
|
|
Referral source
Neurologist/Neurosurgeon
|
1 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
1 Participants
n=273 Participants
|
|
Referral source
Occupational Health
|
3 Participants
n=141 Participants
|
4 Participants
n=132 Participants
|
7 Participants
n=273 Participants
|
|
Referral source
Other
|
0 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=273 Participants
|
|
Referral source
Missing
|
0 Participants
n=141 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=273 Participants
|
|
Comorbidities:
Heart disease
|
45 participants
n=141 Participants
|
4 participants
n=132 Participants
|
49 participants
n=273 Participants
|
|
Comorbidities:
High blood pressure
|
39 participants
n=141 Participants
|
34 participants
n=132 Participants
|
73 participants
n=273 Participants
|
|
Comorbidities:
Poor circulation
|
19 participants
n=141 Participants
|
16 participants
n=132 Participants
|
35 participants
n=273 Participants
|
|
Comorbidities:
Lung disease
|
3 participants
n=141 Participants
|
7 participants
n=132 Participants
|
10 participants
n=273 Participants
|
|
Comorbidities:
Diabetes
|
15 participants
n=141 Participants
|
13 participants
n=132 Participants
|
28 participants
n=273 Participants
|
|
Comorbidities:
Kidney disease
|
1 participants
n=141 Participants
|
2 participants
n=132 Participants
|
3 participants
n=273 Participants
|
|
Comorbidities:
Neurological disorder
|
1 participants
n=141 Participants
|
7 participants
n=132 Participants
|
8 participants
n=273 Participants
|
|
Comorbidities:
Liver disease
|
0 participants
n=141 Participants
|
1 participants
n=132 Participants
|
1 participants
n=273 Participants
|
|
Comorbidities:
Cancer
|
3 participants
n=141 Participants
|
4 participants
n=132 Participants
|
7 participants
n=273 Participants
|
|
Comorbidities:
Depression
|
29 participants
n=141 Participants
|
37 participants
n=132 Participants
|
66 participants
n=273 Participants
|
|
Comorbidities:
Arthritis
|
41 participants
n=141 Participants
|
36 participants
n=132 Participants
|
77 participants
n=273 Participants
|
|
Comorbidities:
None
|
55 participants
n=141 Participants
|
46 participants
n=132 Participants
|
101 participants
n=273 Participants
|
|
Number of Comorbidities
|
1.55 Comorbidities
STANDARD_DEVIATION 1.01 • n=141 Participants
|
1.57 Comorbidities
STANDARD_DEVIATION 1.01 • n=132 Participants
|
1.56 Comorbidities
STANDARD_DEVIATION 1.01 • n=273 Participants
|
|
Independence
Needed assistance to fill in this questionnaire
|
8 participants
n=141 Participants
|
13 participants
n=132 Participants
|
21 participants
n=273 Participants
|
|
Independence
Considers self to have a carer
|
11 participants
n=141 Participants
|
19 participants
n=132 Participants
|
30 participants
n=273 Participants
|
|
Health Literacy - Help needed to read instructions
|
5 participants
n=141 Participants
|
8 participants
n=132 Participants
|
13 participants
n=273 Participants
|
|
Work status - Working
|
75 Participants
n=141 Participants
|
73 Participants
n=132 Participants
|
148 Participants
n=273 Participants
|
|
Hours missed from work in last 7 days because of problem
|
9.13 Hours
STANDARD_DEVIATION 21.24 • n=75 Participants • only working patients
|
8.49 Hours
STANDARD_DEVIATION 31.67 • n=73 Participants • only working patients
|
8.81 Hours
STANDARD_DEVIATION 26.8 • n=148 Participants • only working patients
|
|
Hours missed from work in last 7 days for other reasons
|
8.05 Hours
STANDARD_DEVIATION 33.46 • n=75 Participants • only working patients
|
11.45 Hours
STANDARD_DEVIATION 36.82 • n=73 Participants • only working patients
|
9.73 Hours
STANDARD_DEVIATION 35.08 • n=148 Participants • only working patients
|
|
Hours worked in last 7 days
|
28.11 Hours
STANDARD_DEVIATION 18.74 • n=75 Participants • only working patients
|
25.29 Hours
STANDARD_DEVIATION 15.21 • n=73 Participants • only working patients
|
26.72 Hours
STANDARD_DEVIATION 17.09 • n=148 Participants • only working patients
|
|
Joint and muscle symptoms affect productivity
|
4.81 units on a scale
STANDARD_DEVIATION 2.26 • n=75 Participants • only working patients
|
5.21 units on a scale
STANDARD_DEVIATION 1.88 • n=73 Participants • only working patients
|
5.02 units on a scale
STANDARD_DEVIATION 2.07 • n=148 Participants • only working patients
|
|
Joint and muscle symptoms affect ability to do regular daily activities, other than work
|
5.61 units on a scale
STANDARD_DEVIATION 2.19 • n=75 Participants • only working patients
|
5.71 units on a scale
STANDARD_DEVIATION 2.03 • n=73 Participants • only working patients
|
5.66 units on a scale
STANDARD_DEVIATION 2.10 • n=148 Participants • only working patients
|
|
Percent work time missed due to problem
|
22 Percentage of work time
STANDARD_DEVIATION 36 • n=66 Participants • Working only excluding missing
|
16 Percentage of work time
STANDARD_DEVIATION 30 • n=68 Participants • Working only excluding missing
|
19 Percentage of work time
STANDARD_DEVIATION 33 • n=134 Participants • Working only excluding missing
|
|
Percent impairment while working due to problem
|
48 Percentage of impairment
STANDARD_DEVIATION 23 • n=58 Participants • Working only excluding missing
|
52 Percentage of impairment
STANDARD_DEVIATION 16 • n=63 Participants • Working only excluding missing
|
50 Percentage of impairment
STANDARD_DEVIATION 21 • n=121 Participants • Working only excluding missing
|
|
Percent overall work impairment due to problem
|
52 percentage of overall work impairment
STANDARD_DEVIATION 25 • n=57 Participants • Working only excluding missing
|
56 percentage of overall work impairment
STANDARD_DEVIATION 20 • n=63 Participants • Working only excluding missing
|
54 percentage of overall work impairment
STANDARD_DEVIATION 22 • n=120 Participants • Working only excluding missing
|
|
Percent activity impairment due to problem
|
56 percentage of activity impairment
STANDARD_DEVIATION 22 • n=75 Participants • Working only excluding missing
|
57 percentage of activity impairment
STANDARD_DEVIATION 20 • n=73 Participants • Working only excluding missing
|
57 percentage of activity impairment
STANDARD_DEVIATION 21 • n=148 Participants • Working only excluding missing
|
PRIMARY outcome
Timeframe: 2 weeksA measure of patient empowerment. Scale: Much better / Much more = 2 Better / More = 1 Same or less = 0 Not applicable = 9
Outcome measures
| Measure |
MSK-Tracker (Before)
n=75 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=66 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Patient Enablement Instrument (PEI)
|
1.48 units on a scale
Standard Deviation 1.97
|
1.50 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 3 monthsThis questionnaire is about joint, back, neck, bone and muscle symptoms such as aches, pains and/or stiffness. Min score = 0; Max score = 56. A higher score indicates better outcome.
Outcome measures
| Measure |
MSK-Tracker (Before)
n=141 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=132 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Musculoskeletal Health Questionnaire (MSK-HQ)
Baseline
|
24.32 units on a scale
Standard Deviation 8.26
|
24.45 units on a scale
Standard Deviation 9.83
|
|
Musculoskeletal Health Questionnaire (MSK-HQ)
2-week
|
26.63 units on a scale
Standard Deviation 9.50
|
24.62 units on a scale
Standard Deviation 10.09
|
|
Musculoskeletal Health Questionnaire (MSK-HQ)
3-month
|
27.17 units on a scale
Standard Deviation 10.61
|
26.23 units on a scale
Standard Deviation 11.02
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks and 3 monthsPopulation: Loss to follow up
The CHAIv1 was developed for use among diverse patients to provide a measure of patient activation. Min score = 0, Max score = 100. A high score represents a better outcome. "low" (CHAI score 0-79), "moderate" (CHAI score 80-94), and "high" (CHAI score 95-100).
Outcome measures
| Measure |
MSK-Tracker (Before)
n=141 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=132 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Consumer Health Activation Index (CHAI)
Baseline
|
71.42 units on a scale
Standard Deviation 15.8
|
68.79 units on a scale
Standard Deviation 14.68
|
|
Consumer Health Activation Index (CHAI)
2-weeks
|
73.24 units on a scale
Standard Deviation 12.65
|
71.03 units on a scale
Standard Deviation 13.61
|
|
Consumer Health Activation Index (CHAI)
3-months
|
72.72 units on a scale
Standard Deviation 15.02
|
72.14 units on a scale
Standard Deviation 12.25
|
SECONDARY outcome
Timeframe: 2 weeksScale 1 - Care and Respect Min score = 0, Max score = 15 Higher score indicates a better outcomes. Scale 2 - Understanding and Engagement: Min score = 0, Max score = 15. Higher score indicates a better outcomes.
Outcome measures
| Measure |
MSK-Tracker (Before)
n=80 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=70 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Valuing Patients as Individuals Scale (Short Version)
Care and respect
|
13.1 units on a scale
Standard Deviation 2.13
|
12.99 units on a scale
Standard Deviation 1.75
|
|
Valuing Patients as Individuals Scale (Short Version)
Understanding & engagement
|
12.71 units on a scale
Standard Deviation 2.18
|
12.49 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: 2 weeks and 3 monthsPopulation: Loss to follow up
The response to the question: "With respect to your joint and muscle symptoms, how would you describe yourself now compared to how it was when you came to the Haywood clinic?" Much better = 5 Better = 4 Same = 3 Worse = 2 Much worse = 1 Prefer not to say = 9
Outcome measures
| Measure |
MSK-Tracker (Before)
n=82 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=70 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
Global Rating of Change (1 Item)
2-weeks
|
2.91 Score
Standard Deviation 0.74
|
2.71 Score
Standard Deviation 0.68
|
|
Global Rating of Change (1 Item)
3-months
|
2.98 Score
Standard Deviation 1.01
|
2.82 Score
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 3 monthsA measure of patient empowerment Min score = 0, Max score = 12. Higher score indicated better outcome.
Outcome measures
| Measure |
MSK-Tracker (Before)
n=62 Participants
Usual Care in clinic consultations
|
MSK-Tracker (After)
n=56 Participants
Use of the MSK-Tracker in clinic consultations
MSK-Tracker: The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
* Pre-clinic preparation.
* Clinic dashboard.
* Summary action plan.
* Personal goal setting.
* Follow-up and monitoring.
|
|---|---|---|
|
The Patient Enablement Scale
|
1.82 units on a scale
Standard Deviation 2.12
|
2.12 units on a scale
Standard Deviation 3.33
|
Adverse Events
MSK-Tracker (Before)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MSK-Tracker (After)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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