Back to resultsA Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Primary Purpose
Chronic Pain, Obesity, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MORPH
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Older Adults, Physical Activity, MORPH, Telecoaching, mHealth, Weight Loss, Sedentary Behavior, Pain, Design, RCT, Randomized Controlled Trial
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
- Current participation in other research study targeting pain, physical activity, or weight loss
Sites / Locations
- Wake Forest Baptist Medical Center Pain Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Participants receive the MORPH intervention.
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Outcomes
Primary Outcome Measures
Change in PROMIS Pain Intensity Scale
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.
Change in PROMIS Pain Interference Scale
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
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.
Secondary Outcome Measures
Change in Weight
Weight will be assessed weekly.
Activity Minutes
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).
Sitting Time
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
Sit to Stand Transitions
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
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
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.
Full Information
NCT ID
NCT03377634
First Posted
December 14, 2017
Last Updated
December 29, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03377634
Brief Title
A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Official Title
A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Obesity, Sedentary Lifestyle
Keywords
Older Adults, Physical Activity, MORPH, Telecoaching, mHealth, Weight Loss, Sedentary Behavior, Pain, Design, RCT, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants receive the MORPH intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Intervention Type
Behavioral
Intervention Name(s)
MORPH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PROMIS Pain Intensity Scale
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in PROMIS Pain Interference Scale
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in Short Physical Performance Battery
Description
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.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Weight
Description
Weight will be assessed weekly.
Time Frame
Baseline to 12 weeks
Title
Activity Minutes
Description
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).
Time Frame
Baseline and Week 12
Title
Sitting Time
Description
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
Time Frame
Week 12
Title
Sit to Stand Transitions
Description
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).
Time Frame
Baseline and Week 13
Title
Participant Retention
Description
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.
Time Frame
Baseline to 12 weeks
Title
Utilization of Study Application
Description
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.
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Current participation in other research study targeting pain, physical activity, or weight loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber K Brooks, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center Pain Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33817686
Citation
Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ, Nesbit B, Ford S. A Mobile Health Behavior Intervention to Reduce Pain and Improve Health in Older Adults With Obesity and Chronic Pain: The MORPH Pilot Trial. Front Digit Health. 2020 Dec;2:598456. doi: 10.3389/fdgth.2020.598456. Epub 2020 Dec 18.
Results Reference
derived
PubMed Identifier
29759957
Citation
Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ. A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial. JMIR Res Protoc. 2018 May 14;7(5):e128. doi: 10.2196/resprot.9712.
Results Reference
derived
Learn more about this trial
A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
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