A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
2020년 12월 29일 업데이트: Wake Forest University Health Sciences
A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
33
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
North Carolina
-
Winston-Salem, North Carolina, 미국, 27157
- Wake Forest Baptist Medical Center Pain Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention
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.
|
|
간섭 없음: Control
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in PROMIS Pain Intensity Scale
기간: 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.
|
Baseline to 12 weeks
|
|
Change in PROMIS Pain Interference Scale
기간: 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.
|
Baseline to 12 weeks
|
|
Change in Short Physical Performance Battery
기간: 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.
|
Baseline to 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Weight
기간: Baseline to 12 weeks
|
Weight will be assessed weekly.
|
Baseline to 12 weeks
|
|
Activity Minutes
기간: Baseline and Week 12
|
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).
|
Baseline and Week 12
|
|
Sitting Time
기간: Week 12
|
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
|
Week 12
|
|
Sit to Stand Transitions
기간: Baseline and Week 13
|
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).
|
Baseline and Week 13
|
|
Participant Retention
기간: 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.
|
Baseline to 12 weeks
|
|
Utilization of Study Application
기간: 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.
|
Baseline to 12 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Amber K Brooks, MD, Wake Forest University Health Sciences
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 8월 7일
기본 완료 (실제)
2020년 2월 28일
연구 완료 (실제)
2020년 2월 28일
연구 등록 날짜
최초 제출
2017년 12월 14일
QC 기준을 충족하는 최초 제출
2017년 12월 14일
처음 게시됨 (실제)
2017년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 29일
마지막으로 확인됨
2020년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
MORPH에 대한 임상 시험
-
University of Sao Paulo General Hospital완전한
-
Meril Life Sciences Pvt. Ltd.알려지지 않은