Trial Outcomes & Findings for A Mobile Intervention to Reduce Pain and Improve Health (MORPH) (NCT NCT03377634)

NCT ID: NCT03377634

Last Updated: 2021-01-22

Results Overview

The Pain Interference Scale captures the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse interference. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2021-01-22

Participant Flow

Five participants were assigned to an usability testing period. For the duration of this period, intervention staff kept detailed notation of software and usability challenges, and iterations were made according to information gathered from this period. Notably, these iterations do not affect the overarching structure of the intervention, but will ensure all components of the program are maximally usability for the older adult with chronic pain.

Participant milestones

Measure	Intervention Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Intervention Usability Testing Period STARTED	5	0
Intervention Usability Testing Period COMPLETED	5	0
Intervention Usability Testing Period NOT COMPLETED	0	0
Study Period STARTED	15	13
Study Period COMPLETED	13	13
Study Period NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Intervention Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Study Period Adverse Event	1	0
Study Period Withdrawal by Subject	1	0

Baseline Characteristics

A Mobile Intervention to Reduce Pain and Improve Health (MORPH)

Baseline characteristics by cohort

Measure	Intervention n=15 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.	Total n=28 Participants Total of all reporting groups
Age, Continuous	70.12 years STANDARD_DEVIATION 5.43 • n=93 Participants	70.32 years STANDARD_DEVIATION 5.20 • n=4 Participants	70.21 years STANDARD_DEVIATION 5.22 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	9 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	13 participants n=4 Participants	28 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Three subjects did not do follow up visits in the intervention arm.

The Pain Intensity Scale tasks participants with rating how much they hurt on a scale of 1 (had no pain) to 5 (very severe). Final scores are given as T-scores, with higher scores representing worse intensity. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.

Outcome measures

Measure	Intervention n=12 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Change in PROMIS Pain Intensity Scale	-8.08 units on a scale Standard Deviation 9.00	-1.92 units on a scale Standard Deviation 5.71

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Three subjects did not do follow up visits in the intervention arm.

The Pain Interference Scale captures the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse interference. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.

Outcome measures

Measure	Intervention n=12 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Change in PROMIS Pain Interference Scale	2.76 units on a scale Standard Deviation 10.54	3.11 units on a scale Standard Deviation 5.97

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Three subjects did not do follow up visits in the intervention arm.

This test of lower-extremity function consists of 4-m walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance) resulting in a final score of 0-12. Higher scores denotes better outcomes.

Outcome measures

Measure	Intervention n=12 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Change in Short Physical Performance Battery	0.67 score on a scale Standard Deviation 1.50	0.00 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: One subject did not do follow up visits in the intervention arm.

Weight will be assessed weekly.

Outcome measures

Measure	Intervention n=14 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Change in Weight	-2.27 kg Standard Deviation 4.34	-0.18 kg Standard Deviation 1.55

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Only 9 in each arm with 2+ days of valid data at each time point

Activity Minutes will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess (a) number of daily minutes spent in light-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of light activity are favorable); (b) number of daily minutes spent in moderate-intensity physical activity as reported by the ActivPal (range: 0-1440, more minutes of moderate activity are favorable).

Outcome measures

Measure	Intervention n=9 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=9 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Activity Minutes Baseline	53 minutes per day Standard Deviation 23.57	73.35 minutes per day Standard Deviation 46.42
Activity Minutes Week 12	51 minutes per day Standard Deviation 27.08	62.70 minutes per day Standard Deviation 35.53

SECONDARY outcome

Timeframe: Week 12

Population: Only 9 subjects had 2+ days of valid data at each time point

daily minutes of sedentary time as recorded on the ActivPALTM 4 device

Outcome measures

Measure	Intervention n=9 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=9 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Sitting Time baseline	698.48 minutes per day Standard Deviation 123.29	642.12 minutes per day Standard Deviation 176.48
Sitting Time Week 12	682.26 minutes per day Standard Deviation 182.49	684.86 minutes per day Standard Deviation 154.92

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Only 9 subjects in each arm with 2+ days of valid data at each time point

Transitions will be assessed using ActivPal activity monitors (PAL Technologies Ltd, Glasgow, UK) worn at the thigh for 7 consecutive days. We will assess number of daily transitions from sitting to non-sitting behavior, captured via the ActivPal inclinometer (range: 0 - infinity; a higher number of transitions are favorable).

Outcome measures

Measure	Intervention n=9 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=9 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Sit to Stand Transitions baseline	31.33 number of transitions per day Standard Deviation 10.20	36.44 number of transitions per day Standard Deviation 9.72
Sit to Stand Transitions Week 12	29.22 number of transitions per day Standard Deviation 11.33	37.44 number of transitions per day Standard Deviation 10.55

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Three lost to follow-up from intervention arm.

The extent to which participants were retained in the study (minimum retention goal of 80%). The number of participants that complete the study over the number that were enrolled.

Outcome measures

Measure	Intervention n=15 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 Participants The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Participant Retention	80 percentage of subjects completing	100 percentage of subjects completing

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: This outcome only pertains to the intervention arm.

The extent to which participants utilize the study application, as defined by an average weekly use of 7 application accesses per week for the duration of the study period.

Outcome measures

Measure	Intervention n=15 Participants Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Utilization of Study Application	10.84 number of times accessing per week Standard Deviation 9.64	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=15 participants at risk Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 participants at risk The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Gastrointestinal disorders small intestinal bleed	0.00% 0/15 • Baseline through Week 12	7.7% 1/13 • Number of events 1 • Baseline through Week 12

Other adverse events

Measure	Intervention n=15 participants at risk Participants receive the MORPH intervention. MORPH: Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.	Control n=13 participants at risk The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Baseline through Week 12	7.7% 1/13 • Number of events 1 • Baseline through Week 12
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	13.3% 2/15 • Number of events 2 • Baseline through Week 12	0.00% 0/13 • Baseline through Week 12
Infections and infestations Strep Throat	6.7% 1/15 • Number of events 1 • Baseline through Week 12	0.00% 0/13 • Baseline through Week 12
Infections and infestations Sinusitis	6.7% 1/15 • Number of events 1 • Baseline through Week 12	7.7% 1/13 • Number of events 1 • Baseline through Week 12
Respiratory, thoracic and mediastinal disorders Bronchitis	6.7% 1/15 • Number of events 1 • Baseline through Week 12	0.00% 0/13 • Baseline through Week 12
Nervous system disorders myasthenia gravis	6.7% 1/15 • Number of events 1 • Baseline through Week 12	0.00% 0/13 • Baseline through Week 12

Additional Information

Amber Brooks, MD

Wake Forest University School of Medicine

Phone: 336-716-4498

Email: akbrooks@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place