Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377634
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE August 7, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
Official Title  ICMJE A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Obesity
  • Sedentary Lifestyle
Intervention  ICMJE Behavioral: MORPH
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.
Study Arms  ICMJE
  • Experimental: Intervention
    Participants receive the MORPH intervention.
    Intervention: Behavioral: MORPH
  • No Intervention: Control
    The wait list control participants receive usual care and are offered intervention materials on completion of the study.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2017)
45
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 79 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377634
Other Study ID Numbers  ICMJE IRB00046364
1R21AG058249-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Amber K Brooks, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP