Reablement in Residential Aged Care - a Randomized Controlled Trail (Re-RAC)

A Reablement Intervention in Residential Aged Care (Re-RAC): Study Protocol for a Multi-center, Pragmatic Randomized Controlled, Open-label Trial

Background: The global increase in older adults presents challenges for maintaining health and autonomy in residential aged care (RAC) facilities, where passivity has been shown to often diminish quality of life. However, the reablement approach, which enhances independence through personalized, multidisciplinary strategies, shows promise for addressing these issues and requires further evaluation, particularly in Swedish contexts.

The research project Reablement in RAC (Re-RAC) aims to evaluate the impact of the Re-RAC intervention on activity performance and satisfaction, participation, quality of life and well-being, and health economic outcomes for older adults in RAC facilities, while also describe participant and staff experiences.

Methods: This study is a multi-center prospective pragmatic randomized controlled trial with two parallel groups that will evaluate the Re-RAC intervention compared to treatment as usual, using quantitative, qualitative and health economic methods.

The Re-RAC intervention begins with an interview according to Canadian Occupational Performance Measure (COPM) to identify a meaningful goal, followed by a personalized support plan with training activities, supported by nursing staff. The intervention lasts 8 weeks, with adjustments made based on progress, and ends with a COPM reassessment of the participant's performance and satisfaction. Eighty-six participants will be included, assessed for performance (COPM-performance), satisfaction (COPM-satisfaction), health-related quality of life (EQ-5D-5L), psychological well-being (WHO-5), and physical activity levels (measured by an accelerometer), before and after the intervention. Pain will also be assessed for potential associations with other outcomes. Participants' and staff's experiences will be described through interviews, and cost-effectiveness will be evaluated by calculating the cost per quality adjusted life-years gained.

Discussion: The Re-RAC project evaluates the impact of a reablement intervention on activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities through a pragmatic randomized controlled trial, with assessments before and after the 8-week intervention. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results of this study will offer valuable insights to inform the future implementation and assessment of reablement interventions in RAC settings.

Study Overview

• Status: Recruiting
• Conditions: Older People
• Intervention / Treatment: Other: Reablement intervention; Other: Control group

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Associate professor; Phone Number: +46 70 5554587; Email: kajsa.lidstrom-holmqvist@regionorebrolan.se

Study Locations

• Sweden
  • Örebro County
    • Örebro, Örebro County, Sweden, 70185
      • Recruiting
      • University Health Care Research Center
      • Contact: Kajsa Lidström Holmqvist, Associate professor; Phone Number: 0046 70 5554587

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Older adults aged 65 years and above, residing in a somatic ward at one of the RAC facilities where the study will be conducted, and meeting the inclusion criteria, are eligible to participate in the study. The inclusion criteria require that the older adult must be able to engage in conversations in Swedish and be able to participate in both the assessments and the intervention.

Exclusion Criteria: Persons having severe cognitive impairment (≤17) according to Mini Mental State Examination-Swedish version (MMSE-SR; screening for cognitive function) or being very severely frail or terminally ill according to Clinical Frailty Scale (≥8) (CFS-9) will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reablement intervention; Participants recieve reablement intervention	Other: Reablement intervention; Reablement's implementation in this study is characterized by a comprehensive assessment of the older person's everyday activities, both current and past. This is done through a person-centered interview using the Canadian Occupational Performance Measure (COPM). The COPM is based on the assumptions described in the theoretical framework of CMOP-E. Based on the assessment, the older adult selects a personal activity goal, which consists of an activity they consider meaningful and wish to improve. In collaboration with the older adult and staff, a goal-oriented support plan, also referred to as a training program, is developed to achieve the goal. Nursing assistant staff support the older persons in performing defined training activities and receive supervision from rehabilitation staff. The support plan and progress toward the activity goal are evaluated through regular reassessments during a fixed intervention period of eight weeks.; Other Names: Re-RAC
Active Comparator: Control group; Participants recieve treatment as usual which is conventional care	Other: Control group; TAU includes a general approach where all activities that the older adult engages in during everyday life are considered rehabilitative. The staff are encouraged to motivate the older adult to do as much as possible independently, in order to prevent loss of function and maintain the ability to perform activities. The approach does not involve any direction toward specific activities where there is a rehabilitative need. It does not include any formulated goals or follow-up. Additionally, there is no specific education offered to the nursing assistants on how to encourage the older adult or how to follow-up up on the extent to which the approach is applied.; Other Names: Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in occupational performance related to the prioritized activity, measured with the COPM-P	The COPM is an interview-administered instrument used to assess occupational performance (COPM-P) and satisfaction with performance (COPM-S) for up to five self-determined activity issues in the areas of self-care, productivity, and leisure. Participants will rate their performance and satisfaction with their highest-priority activity on a scale of 1-10, where 1 = unable to perform at all/not satisfied at all, and 10 = able to perform extremely well/extremely satisfied.	From enrollment to the end of treament after 8 weeks

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 282513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No