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Completed

NCT Number: NCT03102814

The BRIDGE Rehabilitation Trial

The main aim of this multi-centre stepped wedge randomized controlled trial is to improve the quality, professional practice and cost-effective utilization of health care resources by evaluating if a new rehabilitation program aimed at bridging gaps in rehabilitation across levels of care may increase and/or prolong the effect of rehabilitation.

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Key information

Conditions

Musculoskeletal Disease Musculoskeletal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valnesfjord Rehabilitation Centre, Valnesfjord, Norway

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About this study

The goal of rehabilitation is to help people to reach and maintain their optimal functioning and coping capabilities, and to promote independence and participation in society. According to current political documents, there are large variation in the content and quality of rehabilitation in Norway, and systems to improve coordination and communication are needed.

This trial is a collaborative project between eight centres across Norway, investigating whether a new program aimed at bridging gaps in rehabilitation across levels of care increase and/or prolong the effect of rehabilitation for people with rheumatic and musculoskeletal diseases. Additionally, we will use a newly developed set of quality indicators to monitor and compare the quality of rehabilitation across different centres, and explore relationships between adherence to structure and process indicators and the outcomes of rehabilitation.

The effects will be evaluated in a multi-centre stepped wedge randomized controlled trial, where participating centres switch from control (current rehabilitation program) to intervention phase (adding the BRIDGE program to the current program) in a randomized order. Primary outcome is goal attainment after seven months, and secondary outcomes are health related quality of life and function.

The results will give insight in the content and organisation of current rehabilitation programs, what follow-up people want and receive in primary care, their planned and completed efforts to implement and maintain life style changes, and predictors for improvement following rehabilitation in specialist health care. Results will also have consequences on how rehabilitation is to be organized in the future regarding follow-up and coordination across levels of care.

The study has been developed in close collaboration with patient research partners, clinicians and international experts, who will also contribute in the process of integrating study results in clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inflammatory rheumatic disease or osteoarthritis or fibromyalgia or low back pain or wide spread pain or osteoporosis. Having a good understanding of Norwegian and having a bank-ID

Exclusion criteria

  • Cognitive impairment or severe psychiatric disorder

Treatment and study plan

Current rehabilitation

Behavioral

The control group will receive the rehabilitation currently offered at each of the participating centers.

The BRIDGE program

Behavioral

The experimental group will additionally receive the BRIDGE program, which comprises motivational interviewing, structured goal-setting, tailored follow-up, plans for self-management, and individualised written feedback that participants can use to monitor their progress and share with important care givers.

Primary outcomes

  1. Goal attainment measured by the Patient Specific Functional Scale

    Time frame: One year

    Goal attainment will be measured by the Patient Specific Functional Scale

Secondary outcomes

  1. Health-related quality of life measured by the EQ5D

    Time frame: One year

    Health-related quality of life will be measured by the EQ5D

  2. Physical function measured by the 30 sec sit to stand test

    Time frame: One year

    Physical function will be measured by the 30 sec sit to stand test

Other outcomes

  1. Pain measured on a numeric rating scale

    Time frame: One year

    Pain will be measured on a numeric rating scale

  2. Fatigue measured on a numeric rating scale

    Time frame: One Year

    Fatigue will be measured on a numeric rating scale

  3. Motivation for goal attainment measured on a numeric rating scale

    Time frame: Baseline

    Motivation for goal attainment will be measured on a numeric rating scale

  4. Function in daily activities measured by the Hannover Functional Ability Questionnaire

    Time frame: One year

    Daily activities will be measured by the Hannover Functional Ability Questionnaire

  5. Coping measured by the Effective Musculoskeletal Consumer Scale

    Time frame: One year

    Coping will be measured by the Effective Musculoskeletal Consumer Scale

  6. Mental health measured by the Hopkins Symptom Checklist

    Time frame: One year

    Mental health will be measured by the Hopkins Symptom Checklist

  7. Participation measured by participation scale in COOP/WONCA

    Time frame: One year

    Participation will be measured by participation scale in COOP/WONCA

Sponsors and collaborators

Lead sponsor

National Resource Center for Rehabilitation in Rheumatology

Other

Collaborators

  • Haugesund Rheumatism Hospital
  • Lillehammer Rheumatism Hospital
  • Meråker Rehabilitation Centre
  • Muritunet Rehabilitation Centre
  • Rehab Vest Rehabilitation Centre
  • Sorlandet Hospital HF
  • Valnesfjord Rehabilitation Centre
  • Vikersund Rehabilitation Centre

Registry information

Official study title

The BRIDGE Trial: A Multicenter RCT to Improve Continuity and Quality in Rehabilitation of People With Rheumatic and Musculoskeletal Diseases

Acronym: BRIDGE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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