Trial Outcomes & Findings for Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit (NCT NCT03285958)

Last Updated: 2021-10-04

Results Overview

The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

Baseline, eight weeks

Results posted on

2021-10-04

Participant Flow

No significant pre-assignment events.

Participant milestones

Participant milestones
Measure	STEPS Intervention Group Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Overall Study STARTED	33	24
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	STEPS Intervention Group Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Not able to attend required orientation	3	0

Baseline Characteristics

Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STEPS Intervention Group n=28 Participants Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group n=23 Participants Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.	Total n=51 Participants Total of all reporting groups
Age, Continuous	71.3 years STANDARD_DEVIATION 7.1 • n=5 Participants	69.3 years STANDARD_DEVIATION 6.4 • n=7 Participants	70.4 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	23 participants n=7 Participants	51 participants n=5 Participants
Pain intensity in last week	5.1 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	5.4 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	5.2 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
PROMIS 4-item pain interference T-score	58.7 units on a scale STANDARD_DEVIATION 6.1 • n=5 Participants	57.0 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	58.0 units on a scale STANDARD_DEVIATION 7.2 • n=5 Participants
PROMIS 4-item physical function difficulty T-score	33.2 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	31.9 units on a scale STANDARD_DEVIATION 4.2 • n=7 Participants	33.0 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants
PROMIS 4-item social partcipation T-score	38.1 units on a scale STANDARD_DEVIATION 7.3 • n=5 Participants	37.0 units on a scale STANDARD_DEVIATION 6.4 • n=7 Participants	37.6 units on a scale STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, eight weeks

Population: This is from the analytic sample that had both baseline and follow-up data on this measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=28 Participants Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group n=23 Participants Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Change in Pain Interference	-0.85 score on a scale Standard Deviation 6.2	-0.21 score on a scale Standard Deviation 6.6

PRIMARY outcome

Timeframe: Two weeks

Population: Intervention group participants with baseline and follow-up data. Excludes one case that did not have a texting plan on her phone. Result represents number of adherent person-days out of all possible person-days for SMS.

Proportion of days that step count was successfully provided/possible reporting days for SMS

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=378 person-days Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Adherence to Step Count Reporting - SMS	299 person-days	—

PRIMARY outcome

Timeframe: two weeks

Population: Intervention group participants with baseline and follow-up data. Excludes one case who did not receive IVR calls on schedule due to system error. Result represents number of adherent person-days out of all possible person-days for IVR.

Proportion of days that step count was successfully provided/possible reporting days for IVR.

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=378 person-days Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Adherence to Step Count Reporting - IVR	257 person-days	—

PRIMARY outcome

Timeframe: two weeks

Population: Intervention group participants with baseline and follow-up data. Result represents number of adherent person-days out of all possible person-days for sync.

Proportion of days that step count was successfully provided/possible reporting days for syncing with app

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=392 person-days Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Adherence to Step Count Reporting - Sync	267 person-days	—

SECONDARY outcome

Timeframe: Baseline, eight weeks

Population: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.

The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=28 Participants Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group n=23 Participants Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Change in Physical Functioning	-1.4 units on a scale (T-score) Standard Deviation 3.5	-0.85 units on a scale (T-score) Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, eight weeks

Population: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value (or smaller positive value) is a better outcome.

Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=28 Participants Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group n=23 Participants Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Change in Social Participation	0.28 units on a scale Standard Deviation 7.8	0.83 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Two weeks

Population: Result is number of person- days with valid data reported that were within 50 steps of sync value.

Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=256 person-days Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Validity of Manually-reported Step Count Data - SMS	133 person-days	—

SECONDARY outcome

Timeframe: Two weeks

Population: Result is number of person- days with valid data reported that were within 50 steps of sync value.

Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

Outcome measures

Outcome measures
Measure	STEPS Intervention Group n=215 person-days Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Validity of Manually Reported Step Count Data - IVR	94 person-days	—

Adverse Events

STEPS Intervention Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

STEPS Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	STEPS Intervention Group n=28 participants at risk Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	STEPS Control Group n=23 participants at risk Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Respiratory, thoracic and mediastinal disorders hospitalization	3.6% 1/28 • Number of events 1 • 8 weeks	0.00% 0/23 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary Janevic

University of Michigan

Phone: 734 647 3194

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place