Older PeopleRe-RACNCT06793501
Reablement in Residential Aged Care - a Randomized Controlled Trail
A study testing Reablement intervention in people with Older People, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older People
- What is being tested?
- Reablement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University Health Care Research Center
Örebro, Örebro County, 70185
Kajsa Lidström Holmqvist, Associate professor, 0046 70 5554587
About this study
Official title: 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.
Read more
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
- Being tested
- Reablement intervention, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reablement interventionOther
Also called Re-RAC
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.
Control groupOther
Also called Treatment as usual
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.
| Study group | Role | What they receive |
|---|---|---|
| Reablement intervention | Experimental | Participants recieve reablement intervention Receives: Other: Reablement intervention |
| Control group | Active comparator | Participants recieve treatment as usual which is conventional care Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treament after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajsa Lidström Holmqvist, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793501
- Sponsor's protocol ID
- 282513
- Acronym
- Re-RAC
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40826363
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reablement Intervention in Residential Aged Care (Re-RAC): Study Protocol for a Multi-center, Pragmatic Randomized Controlled, Open-label Trial
- ClinicalTrials.gov ID
- NCT06793501
- Acronym / sponsor ID
- Re-RAC / 282513
- Conditions
- Older People
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reablement intervention | Experimental | Other: Reablement interventionParticipants recieve reablement intervention |
| Control group | Active comparator | Other: Control groupParticipants recieve treatment as usual which is conventional care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reablement interventionAlso: Re-RACReablement'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 | Reablement intervention |
| Control groupAlso: Treatment as usualTAU 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 | Control group |
Primary outcome
Change in occupational performance related to the prioritized activity, measured with the COPM-P
Time frame: From enrollment to the end of treament after 8 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 40826363Philipson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reablement intervention in people with Older People, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Associate professor (+46 70 5554587, kajsa.lidstrom-holmqvist@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in occupational performance related to the prioritized activity, measured with the COPM-P (time frame: From enrollment to the end of treament after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.