A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
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|ClinicalTrials.gov Identifier: NCT03377634|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Obesity Sedentary Lifestyle||Behavioral: MORPH||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Participants receive the MORPH intervention.
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.
No Intervention: Control
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
- Change in PROMIS Pain Intensity Scale [ Time Frame: Baseline to 12 weeks ]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
- Change in PROMIS Pain Interference Scale [ Time Frame: Baseline to 12 weeks ]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.
- Change in Short Physical Performance Battery [ Time Frame: Baseline to 12 weeks ]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.
- Change in Weight [ Time Frame: Baseline to 12 weeks ]Weight will be assessed weekly.
- Change in Sedentary and Light to Moderate Activity Minutes [ Time Frame: Baseline and Week 13 ]Sedentary & Light to Moderate 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).
- Change in Sedentary and Light to Moderate Activity Transitions [ Time Frame: Baseline and Week 13 ]Sedentary & Light to Moderate Activity 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).
- Participant Retention [ Time Frame: Baseline to 12 weeks ]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.
- Utilization of Study Application [ Time Frame: Baseline to 12 weeks ]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.
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): NCT03377634
|United States, North Carolina|
|Wake Forest Baptist Medical Center Pain Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Amber K Brooks, MD||Wake Forest University Health Sciences|