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Rehabilitation by Recovery of FunctionNCT03565614

Reablement Intervention for Older Adults Conducted by a Multi Professional Home Rehabilitation Team

A study testing Reablement and Traditional home care in people with Rehabilitation by Recovery of Function, run by Mälardalen University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: People live increasingly longer and are expected to function independently in their own homes to a greater extent than before. This puts great demands on the support given to older persons living at home, to be efficient and provide good conditions for them to manage on their own and experience good… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Rehabilitation by Recovery of Function
What is being tested?
Reablement and Traditional home care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteSweden
Study dates
1 Jan 2016to 31 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • older adults, over 65 years
  • residing in the central areas of Eskilstuna municipality
  • applying for social care and services delivered by the municipality of Eskilstuna

Who cannot join

  • life-threatening disease
  • severe mental illness
  • severe cognitive dysfunction
  • other conditions that prevent the participants from expressing their will or desires

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Eskilstuna municipality, Care and social care service, Rehabilitation unit

    Eskilstuna, Södermanland County, 63343

Other trials in Sweden

About this study

Official title: Reablement Intervention for Older Adults Conducted by a Multi Professional Home Rehabilitation Team: A Randomized Controlled Trial (RCT) With Qualitative Follow-ups of the Intervention

Background: People live increasingly longer and are expected to function independently in their own homes to a greater extent than before. This puts great demands on the support given to older persons living at home, to be efficient and provide good conditions for them to manage on their own and experience good health. Short time goal directed reablement delivered by a multidisciplinary team is expected to strengthen the functional capacity and quality of life, while home care-hours and thus municipal expenditures decline. Theoretical focus of this project is related to international classification of functionality and disability (ICF) in which participation are understood as engagement in life situations and related to the environment as well as the person. Reablement is expected to extend the time of independent and autonomous life for older persons while also reducing municipal costs of elder care.

Aim: This research project measures the effects of reablement in terms of bio-psycho-social health among older people (65+). In addition, the project highlights older person's experiences of the intervention and the professional team´s experiences of working with reablement.

Read more

Methods: This is a randomized controlled study of the intervention reablement performed by the multiprofessional team with controls receiving usual home care. The effects are measured by self-reported health and quality of life, physical capacity, and home care hours. Data are collected at inclusion (applying for home care), after the three months intervention and at six months. Interviews with users are performed after the intervention, and staff experiences through written narratives.

Impact of results: This project will contribute with collecting possible evidence of reablement, and contribute with knowledge development of older persons' bio-psycho-social health and experiences.

Being tested
Reablement, Traditional home care
Keywords
reablement, older people, personal care services, rehabilitation, multimorbidity, disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReablementBehavioural

    Intensive home-based rehabilitation is delivered up to 3 months by an interprofessional team (nurse, enrolled nurse, physiotherapist, occupational therapist, social worker). The entire team completed a 5-week college course. The team negotiates goal-directed contents of the rehabilitation initiatives with the user. Each user is handled deliberately based on decisions in the team in cooperation with the care managers overarching goals in admitted services. All participants have personal contact persons, and these contact persons have twice the time per participant as compared to traditional home care. The interprofessional team also has regular meetings to discuss every participant, and all rehabilitation goals activities related to those are documented.

  • Traditional home careBehavioural

    Traditional home care and required rehabilitation efforts as by the municipality's current practice. Includes the same professions as is included in the reablement intervention, but the team has had no joint college course, does not use the systematic goal-directed and negotiated approach as the reablement intervention, and has about half the time per participant as compared to the reablement intervention.

Study groups in NCT03565614
Study groupRoleWhat they receive
Reablement rehabilitationExperimentalReablement rehabilitation to maintain or increase the participants' physical, psychological and social functional abilities.
Receives: Behavioral: Reablement
Traditional home careActive comparatorThe traditional home care and required rehabilitation efforts as by the municipality's current practice.
Receives: Behavioral: Traditional home care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in self-assessed overall life satisfaction

    Participants' overall life satisfaction ratings are included in the Health as Ability of Acting questionnaire (HACT; Snellman et al. 2011), which is based on Nordenfelt's theory of health (2004). These global ratings are made on a VAS scale, which is coded from 0 (very unsatisfied with life) to 100 (very satisfied with life).

    Measured: Change from baseline overall life satisfaction rating at 6 months

Secondary outcomes (8)
  1. Change in self-assessed general health

    Self-assessed general health is measured with an overall rating from the EQ-5D-5L (Herdman et al., 2011). These global ratings are made on a VAS scale, which is coded from 0 (the best health you can imagine) to 100 (the worst health you can imagine).

    Measured: Change from baseline self-assessed general health ratings at 6 months

  2. Change in self-assessed health-related quality of life

    Self-assessed health-related quality of life in five dimensions, i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, is measured with EQ-5D-5L (Herdman et al., 2011). Each of the five dimensions is rated on a five level response scale, which is coded and reported from 1 (no problems) to 5 (extreme problems).

    Measured: Change from baseline health-related quality of life ratings at 6 months

  3. Change in self-assessed mental health

    Mental health is mirrored with a short version of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM; Elfström et al. 2013, Evans, et al., 2002), called General Practitioner (GP-)CORE (Sinclair et al. 2005). The 14 items in GP-CORE are summarized and divided by 14, forming a total mean score ranging from 0 (no psychological distress) to 4 (maximum psychological distress).

    Measured: Change from baseline mental health ratings at 6 months

  4. Change in self-assessed health with respect to personal priorities

    Participants' ratings from the Health as Ability of Acting questionnaire (HACT; Snellman et al. 2011) are categorized into one of three health groups:

    Good health: (a) Fulfilled vital goals or (b) the person possesses the ability to achieve the unfulfilled vital goals and the intention to use this ability or (c) experiencing a certain degree of ability to achieve vital goals and have the intention to use the ability.

    Acceptable health: (a) Unfulfilled vital goals. The person have a certain degree of ability to achieve goals and the intention to use the ability. (b) Unfulfilled vital goals. The person have a certain degree of ability to achieve these goals but have no intention to use the ability.

    Poor health: (a) experiencing a certain degree of ability to achieve vital goals, judged as important, and the intention to use the ability. (b) Unfulfilled vital goals. The person lacks the ability to achieve the unfulfilled goal or goals, despite judging them as important.

    Measured: Change from baseline self-assessed health with respect to personal priorities at 6 months

  5. Change in self-assessed activity performance satisfaction

    Self-assessed activity performance satisfaction is estimated with interviewer administered Canadian Occupational Performance Measure (COPM; Law et al., 1990). In relation to a central activity problem area that the participants' themselves chose during the interview, the participants' are asked how well they think they can perform up to the five most important activities that relate to the central activity problem area. Then the participants are asked how satisfied they are with their performance, rating each activity performance satisfaction from 1 to 10. Then a mean value is calculated by dividing the sum of activity performance satisfaction ratings by the number of rated activities, giving a mean that can range from 1 (not at all satisfied) to 10 (extremely satisfied).

    Measured: Change from baseline activity performance satisfaction ratings at 6 months

  6. Change in self-assessed activity performance

    Self-assessed activity performance is estimated with interviewer administered Canadian Occupational Performance Measure (COPM; Law et al., 1990). In relation to a central activity problem area that the participants' themselves chose during the interview, the participants' are asked how well they think they can perform up to the five most important activities that relate to the central activity problem area. The participants rate each activity from 1 to 10 regarding how well the can perform the activity. Then a mean value is calculated by dividing the sum of activity performance by the number of activities, giving a mean that can range from 1 (cannot perform the activity at all) to 10 (can perform the activity extremely well).

    Measured: Change from baseline activity performance ratings at 6 months

  7. Change in lower extremities physical activity performance

    Lower extremities physical activity performance is measured by a trained administrator with the Short Physical Performance Battery (SPPB; Guralnik et al., 1994). The SPPB is calculated from three components: the ability to stand for up to 10 seconds with feet positioned in three ways; time to complete a 3-m walk; and time to rise from a chair five times. Each component is scored from 0 to 4, with the scores from the three tests summed to give a total, with a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function.

    Measured: Change from baseline lower extremities physical activity performance at 6 months

  8. Change in upper extremities physical activity performance

    Upper extremities physical activity performance is measured with a hand dynamometer test (Mathiowetz et al., 1985). The Jamar hydrolic hand dynamometer model J00105 is used. The test of each hand is repeated 3 times, and the average is scored by the trained administrator as the recorded result. The resulting grip strength may vary from 0 kilograms (no grip strength) to 90 kilograms (maximum grip strength).

    Measured: Change from baseline upper extremities physical activity ability at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start1 Jan 2016
  3. Primary completion5 Jun 2019
  4. Study completion31 Aug 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Older adults (65+) applying for social care and services delivered by a municipality (Eskilstuna) in the county of Södermanland, Sweden. Presumptive participants are identified by the municipality care mangers. After informed consent, the users are randomized to either the intervention or control group. Exclusion criteria: Life-threatening disease, diagnosed mental illness, or severe cognitive dysfunction that would prevent the participant from expressing wants.
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03565614
Sponsor's protocol ID
IHR (Reablement)
Status last verified
Nov 2019
First submitted
18 Dec 2017
Last updated
18 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication.

Publications

  • Gustafsson LK, Soderman M, Johansson C, Elfstrom ML. Interprofessional homebased reablement intervention for older adults in Sweden: a randomized controlled trial. BMC Geriatr. 2025 Apr 10;25(1):242. doi: 10.1186/s12877-025-05886-w.

    PubMed 40211212

Questions about this trial

What is this clinical trial studying?

A study testing Reablement and Traditional home care in people with Rehabilitation by Recovery of Function, run by Mälardalen University 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?

The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Nov 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-assessed overall life satisfaction (time frame: Change from baseline overall life satisfaction rating at 6 months). 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 NCT03565614, 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 18 Nov 2019.

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