Back to Living Well: Implementation of a Community-based Program for the Secondary and Tertiary Prevention of Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
Low back pain (LBP) is usually a long-term condition with episodes of improvement, remission, and recurrence. There is evidence that long term exercise combined with education and self-management is effective at reducing the negative consequences of LBP. However, problems with uptake and long-term adherence to such programs are often reported in the literature. Using best available evidence, the implementation of the BackToLivingWell (BLW) will be evaluated, a community-based online or in-person program for the prevention long term disability due to LBP through exercise and self management.
详细描述
The study will evaluate the implementation of The Back to Living Well program (BLW), a sustainable community-based program for persons with persistent mild to moderate LBP. The goal of the intervention is to provide an opportunity for community dwelling persons with persistent mild to moderate LBP to learn how to safely engage in exercise and become active self-managers. Through the engagement in exercise and healthy lifestyle behaviours, the program aims to prevent activity-limiting flares as well as minimize the ongoing impact of the condition with improvements in function and quality of life.
Persons with LBP will be invited to participate in either the in-person or e-health program based on their choices. We will conduct a mixed-method study with a quantitative and a qualitative portion. This will include participants completing the program and questionnaires at baseline, 3-, 6- and 12- months, as well as longitudinal qualitative interviews at the same time points to assess: 1) barriers and facilitators to the program, 2) factors that contribute to negative and positive responses to the program. This may include how intervention outcomes are related to the program, personal and societal factors, and 3) factors that influence the selection of in-person versus online intervention.
In addition, to evaluate symptom trajectories, an ecological Momentary Assessment (EMA) will be collecting data over the same time points (baseline, 3-, 6- and 12- months). Weekly outcomes will be collected for 1-year using a smartphone application. The results of this study will provide evidence to inform future implementation of the program including strategies that could lead to better outcomes. Additionally, LiveWell specialists delivering the program and YMCA staff will be interviewed at the end of the program.
Overall, the RE-AIM framework will be used to guide our implementation. Additionally, using the Theoretical Domains Framework, the Technology Acceptance Model and the Neuromatrix Model of Pain we will construct a theory-based approach to:
- Identify program barriers and facilitators from the perspective of the patients,
- Identify factors contributing to negative and positive outcomes as well as outcome trajectories, including how outcomes are related to the program, personal and contextual factors and,
- Identify factors influencing participants to select an in-person or e-health program,
- Evaluation program specific implementation barriers and facilitators from the perspectives of the organization and care delivery perspectives.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently starting or enrolled in the Back to Living Well program at a YMCA in Downtown Hamilton, Les Chater, Ron Edwards, Laurier Brantford or Flamborough
- •Have non-specific LBP
- •History of persistent LBP for 3 or more months that is mild, moderate, or severe
- •If moderate levels of pain or less (pain <6) they must have a history of flares or at least one flare within the previous year, if pain >=6, flare is not necessary.
- •18 years old or older
排除标准
- •Co-morbidity preventing participation in exercise based on screening using the Physical Activity Readiness Questionnaire and later not cleared by their family physician
- •Inadequate English to complete questionnaires and interviews
- •Participants who are currently seeking care for LBP
研究组 & 干预措施
In-Person
Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and design an individualized program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. Day 1 will include individualized program at the fitness center, Day 2 will include a group class exercises ending with mindfulness activities, action planning and education. Day 3 will consist of an independent day when participants can attend other classes at the YMCA or repeat the fitness center. In addition, there will be 12 virtual videos of education on self-management that will be discussed during the group activity day (Day 2) .
干预措施: Back to Living Well Program (Other)
e-Health
Participants will be assessed by a LiveWell specialist to assess functional goals and baseline capacity and provide recommendation on exercise modifications and the program. LiveWell specialist may also refer participants for an assessment with a physiotherapist based on a pre-defined criteria including redflag for serious conditions. Participants will engage in a 12-week program consisting of 45 minute sessions 3 times a week. They will be provided with 3 exercise videos (including 3 levels of exercises per video) and will also have access to the on-demand YMCA platform for additional videos. In addition, there will be 12 virtual videos of education on self-management that will be discussed during follow-up phone calls. Participants will also be provided with an action planning document to complete at home. All online participants will have a phone call with the LiveWell specialist at 3 and 7 weeks to discuss the program, action planning and the education materials.
干预措施: Back to Living Well Program (Other)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 12-months
RMDQ is for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. The score ranges from 0 (no disability) to 24 (maximum disability).
次要结局
- Activity Limitation(Once a week for 12 months (week 0-week 52))
- TAMPA Scale of Kinesiophobia(Baseline, 3 months, 6 months & 12 months)
- PROMIS IMPACT(Baseline, 3 months, 6 months & 12 months)
- Treatment Self Regulation Questionnaire(Baseline, 3 months, 6 months & 12 months)
- Coping Strategies Questionnaire(Baseline, 3 months, 6 months & 12 months)
- International Physical Activity Questionnaires(Baseline, 3 months, 6 months & 12 months)
- Pain NRS(Baseline, 3 months, 6 months & 12 months)
- Self Report Flare(Once a week for 12 months (week 0-week 52))
- EQ-5D-5L(Baseline, 3 months, 6 months & 12 months)
- Pain Self-Efficacy Questionnaire(Baseline, 3 months, 6 months & 12 months)
- Pain Catastrophizing Scale(Baseline, 3 months, 6 months & 12 months)
- Center for Epidemiologic Studies Depression Scale(Baseline, 3 months, 6 months & 12 months)
- Exercise Adherence Rating Scale(Baseline, 3 months, 6 months & 12 months)
- Patient Specific Functional Scale(Baseline, 3 months, 6 months & 12 months)
- Adherence exercise(After completion of the program (3 months))
- Adherence education(After completion of the program (3 months))
- EQ-5D-5L(Once a week for 12 months (week 0-week 52))
研究者
Luciana Macedo
Principal Investigator
McMaster University