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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
33
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest Baptist Medical Center Pain Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～79年 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：Control
The wait list control participants receive usual care and are offered intervention materials on completion of the study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in PROMIS Pain Intensity Scale
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Weight
時間枠：Baseline to 12 weeks
|
Weight will be assessed weekly.
|
Baseline to 12 weeks
|
|
Activity Minutes
時間枠：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
時間枠：Week 12
|
daily minutes of sedentary time as recorded on the ActivPALTM 4 device
|
Week 12
|
|
Sit to Stand Transitions
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Amber K Brooks, MD、Wake Forest University Health Sciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年8月7日
一次修了 (実際)
2020年2月28日
研究の完了 (実際)
2020年2月28日
試験登録日
最初に提出
2017年12月14日
QC基準を満たした最初の提出物
2017年12月14日
最初の投稿 (実際)
2017年12月19日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月22日
QC基準を満たした最後の更新が送信されました
2020年12月29日
最終確認日
2020年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
MORPHの臨床試験
-
Meril Life Sciences Pvt. Ltd.わからない