A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in PROMIS Pain Interference Scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Chronic pain contributes to declining health and function in older adults; effects that are intensified by obesity and sedentary (sitting) behavior. The purpose of this study is to develop and test a novel, patient-centered intervention to reduce pain and improve physical function in older, obese adults. The study will utilize a combination of telephone based coaching and smartphone tools to deliver this novel intervention to decrease both body weight and sitting behavior. The long-term goals of this project are to test the efficacy of the intervention and to develop it as a tool for clinicians to provide outside-of-clinic patient-centered support for overweight/obese older adults with chronic pain.
Detailed Description
Chronic pain has emerged as an urgent age-related health issue that significantly effects physical functioning and quality of life, with the unfavorable effects worsened by both obesity and sedentary behavior. The annual cost of pain in the United States is nearly 30% higher than the combined costs of cancer and diabetes. In 2016, the NIH called for a National Pain Strategy to: 1) expand non-pharmacological treatment options in older adults, who are particularly susceptible to the side effects of opioid and other pain medications; 2) develop accessible treatments that are tailored to individuals; and 3) increase the development of self-management programs for chronic pain. The purpose of this R-21 is to develop and test the feasibility and acceptability of a novel, patient-centered intervention to reduce chronic pain and improve physical functioning in older adults, leveraging the combination of telecoaching and individually-adaptive mHealth tools to decrease both body mass and sedentary behavior. A pilot randomized controlled trial will be conducted to provide initial evidence for effect sizes (pain and physical function) associated with the proposed intervention, and to estimate the sample size needed for a full scale randomized controlled trial design that compares the effects of the intervention versus usual care on pain ratings and physical function in overweight/obese older adults with chronic pain.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Own smartphone
- •Pain in 2 of 5 areas (i.e., back, neck, shoulders, hips, knees) on most days during the previous 3 months
- •No contraindication for participation in exercise with approval for participation by their physician
- •Obese (BMI=30-45 kg/m2)
- •Weight-stable (i.e., no weight loss or gain \> 5% in the past 6 months)
- •Low-active (i.e., engaging in less than 2 days/week of structured physical activity for at least 20 minutes).
- •Approved for participation by LMC Pain Center Director and Dr. Brooks
- •Willingness to provide consent; Agree to all study procedures and assessments; Able to provide own transportation to study visits
- •Access to home Wi-Fi and smartphone device
Exclusion Criteria
- •Dependent on cane or walker
- •\>1 fall (injurious or non-injurious) in past year
- •Vision insufficient to read a smartphone screen, unable to read
- •Participation in regular resistance training and/or \> 20 mins/d of aerobic exercise in past 6 months
- •No contraindication to exercise
- •Unable to walk without assistive devices
- •Cognitive impairment as indicated by a Montreal Cognitive Assessment score \< 22
- •Uncontrolled hypertension (\>160/90 mmHg);
- •Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease; cancer requiring treatment in past yr, except non-melanoma skin cancers
- •Regular use of: growth hormones, oral steroids, or prescription osteoporosis medications
Outcomes
Primary Outcomes
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. 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.
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 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. 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.
Secondary Outcomes
- Activity Minutes(Baseline and Week 12)
- Participant Retention(Baseline to 12 weeks)
- Sitting Time(Week 12)
- Sit to Stand Transitions(Baseline and Week 13)
- Change in Weight(Baseline to 12 weeks)
- Utilization of Study Application(Baseline to 12 weeks)