Reablement in Residential Aged Care - a Randomized Controlled Trail

NCT06793501 | Recruiting

• 1 other identifier: 282513
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older People

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Reablement intervention

EXPERIMENTAL

Participants recieve reablement intervention

Other: Reablement intervention

Control group

ACTIVE COMPARATOR

Participants recieve treatment as usual which is conventional care

Other: Control group

Interventions

Reablement intervention OTHER

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.

Also known as: Re-RAC

Reablement intervention

Control group OTHER

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.

Also known as: Treatment as usual

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

University Health Care Research Center

Örebro, Örebro County, 70185, Sweden

RECRUITING

Related Publications (1)

• Philipson A, Lindvall MA, Pettersson C, Stralman L, Holmqvist KL. Reablement in Residential Aged Care (Re-RAC): study protocol for a multi-center pragmatic randomized controlled open-label trial. Trials. 2025 Aug 18;26(1):294. doi: 10.1186/s13063-025-08999-0.

  PMID: 40826363 DERIVED

MeSH Terms

Interventions

Control Groups; Therapeutics

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Associate professor

CONTACT

+46 70 5554587; kajsa.lidstrom-holmqvist@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: October 10, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

SE (1)