A Mobile Intervention to Reduce Pain and Improve Health (MORPH)
2020年12月29日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
33
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Medical Center Pain Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 至 79年 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention
Participants receive the MORPH intervention.
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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.
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无干预：Control
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in PROMIS Pain Intensity Scale
大体时间：Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Change in PROMIS Pain Interference Scale
大体时间：Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Change in Short Physical Performance Battery
大体时间：Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change in Weight
大体时间：Baseline to 12 weeks
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Weight will be assessed weekly.
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Baseline to 12 weeks
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Activity Minutes
大体时间：Baseline and Week 12
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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).
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Baseline and Week 12
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Sitting Time
大体时间：Week 12
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daily minutes of sedentary time as recorded on the ActivPALTM 4 device
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Week 12
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Sit to Stand Transitions
大体时间：Baseline and Week 13
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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).
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Baseline and Week 13
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Participant Retention
大体时间：Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Utilization of Study Application
大体时间：Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Amber K Brooks, MD、Wake Forest University Health Sciences
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年8月7日
初级完成 (实际的)
2020年2月28日
研究完成 (实际的)
2020年2月28日
研究注册日期
首次提交
2017年12月14日
首先提交符合 QC 标准的
2017年12月14日
首次发布 (实际的)
2017年12月19日
研究记录更新
最后更新发布 (实际的)
2021年1月22日
上次提交的符合 QC 标准的更新
2020年12月29日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
MORPH的临床试验
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University of Sao Paulo General Hospital完全的
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Meril Life Sciences Pvt. Ltd.未知