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Improving multimodal physical function in adults with heterogeneous chronic pain; Multi-site feasibility RCT

改善患有异质性慢性疼痛的成人的多模式身体功能；

基本信息

批准号：
10509806
负责人：
Jonathan Greenberg
金额：
$ 58.09万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10509806
关键词：
Accountability Address Adherence Adult Ambulatory Monitoring Area Benchmarking Chronic Classification Clinical Trials Competence Complementary Health Data Enrollment Ensure Expectancy Feedback Focus Groups Funding Future Geography Goals Health Impairment Individual Integrative Medicine International Intervention Interview Measurement Measures Methodology Methods Mission Motivation Musculoskeletal Musculoskeletal Pain National Center for Complementary and Integrative Health Non-Malignant Outcome Pain Pain Clinics Pain Measurement Participant Patient Self-Report Patients Performance Persons Physical Function Physical activity Population Preparation Procedures Protocols documentation Psychological reinforcement Public Health Publications Questionnaires Randomized Randomized Clinical Trials Recommendation Relaxation Research Research Project Grants Sampling Signal Transduction Single-Blind Study Site Surveys Testing Time Training Vision Walking acceptability and feasibility actigraphy base body-mind chronic musculoskeletal pain chronic pain chronic pain management chronic pain patient cost disability efficacy trial emotional functioning ethnic minority evidence based guidelines fitbit follow-up implementation protocol impression improved improved outcome innovation meetings multi-site trial multimodality novel patient oriented preference programs psychosocial racial and ethnic racial minority recruit resilience response routine care satisfaction sedentary skills success theories

项目摘要

PROJECT SUMMARY Chronic pain is costly, challenging to treat, and associated with substantial impairment in physical function. Mild physical activity such as walking is safe but engagement and adherence are problematic. IMMPACT criteria and the ICF frameworks recommend that all chronic pain clinical trials assess and target physical function comprehensively using not only self- report, but also performance based and ambulatory monitoring of activity (e.g., objective). No clinical trials to date have followed these recommendations. A mind body program adapted for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals increase step count using a Fitbit to provide accountability to goals may be efficacious in improving all aspects of physical function. To begin testing these hypotheses we completed an R34 NCCIH funded project, in which we: 1) adapted a multimodal, theory grounded mind body program (The Relaxation Response Resilience Program; 3RP) for the unique needs of patients with chronic non-malignant, musculoskeletal pain and to specifically target increased walking (their preferred activity) through time goals (GetActive) or step count goals measured and reinforced by a Fitbit (GetActive-Fitbit); 2) completed an open pilot with exit interviews of the 2 programs; and 3) conducted an RCT of the 2 programs and established single site feasibility, acceptability and fidelity benchmarks including similar signal of improvement in physical function measurements. Directly building upon this successful trial, we now propose a multisite pilot RCT implemented at MGH and 2 additional geographically diverse sites (Rush and Duke) of GetActive-Fitbit (with evidence of superiority over GetActive from quantitative and qualitative data) vs a Health Enhancement Program (HEP). We will establish: 1) multi-site fidelity to training and protocol; and 2) multi-site feasibility and acceptability of study procedures including recruitment of sedentary individuals who benefit the most from this program and a sample of racial and ethnic minorities that is representative of the USA (38%, 2020 numbers) .We will also refine our protocols using qualitative information from staff and participants to set the stage for a large, multi-site efficacy RCT and subsequent implementation of GetActive-Fitbit in routine care of chronic pain patients.

项目总结