Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit
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|ClinicalTrials.gov Identifier: NCT03285958|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: STEPS Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies|
|Actual Study Start Date :||November 16, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: 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.
Behavioral: 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.
No Intervention: 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 [ Time Frame: Six weeks ]Proportion of days that step count was successfully provided/possible reporting days
- Change in pain interference [ Time Frame: Baseline, six weeks ]Participants will be asked to rate their pain interference on the PROMIS-29, where a higher score indicates more pain interference.
- Change in physical functioning [ Time Frame: Baseline, six weeks ]Participants will be asked to rate their physical functioning on the PROMIS-29, where a higher score indicates more difficulty in functioning.
- Participants will be asked to rate their participation in social roles on the PROMIS-29, where a higher score indicates more difficulty in participating. [ Time Frame: Baseline, six weeks ]from PROMIS-29
- Validity of manually-reported step count data [ Time Frame: One week ]Correlation of manually-reported with automatically uploaded data - percentage of days that counts are within 50 steps of each other
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285958
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mary Janevic||University of Michigan School of Public Health|