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

Wake Forest University (WFU)

Status: Completed

Conditions: Chronic Pain; Obesity; Sedentary Lifestyle

Treatments: Behavioral: MORPH

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03377634

IRB00046364

1R21AG058249-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 65 to 79 years old

Volunteers: No Healthy Volunteers

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
• Current participation in other research study targeting pain, physical activity, or weight loss

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants receive the MORPH intervention.

Treatment:

Behavioral: MORPH

Control

No Intervention group

Description:

The wait list control participants receive usual care and are offered intervention materials on completion of the study.