ReablementNCT06749080
ASSIST 2.0: a Reablement Program for Healthy Ageing
A study testing Assist Reablement (including education and mentoring) in people with Reablement and Frailty, run by Aileen Bergström at 2 sites in Sweden.
Trial summary
The goal of this study is to continue to develop, implement, and evaluate a unique reablement service, ASSIST 2.0. The project will determine the differences in the reablement service (ASSIST 2.0) compared to regular home care in terms of older adults' performance in daily activities, self-efficacy, perceived health… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reablement, Frailty
- What is being tested?
- Assist Reablement (including education and mentoring)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 3 Feb 2025to Sep 2028
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Homecare has been granted
- The person can describe an ordinary day and what they have problems with doing
- 65 years of age or over
Who cannot join
- The person has palliative care
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Susanne Assander, PhD contact
Sweden2 sites, 1 recruiting
- Active, not recruiting
Karolinska Institutet
Huddinge, Sweden, 181 83
- Recruiting
Uppsala Kommun
Uppsala, Sweden, 753 75
Kajsa Rosen, Physical Therapist (MAR), +46 18-727 84 48, kajsa.rosen@uppsala.se
About this study
The goal of this study is to continue to develop, implement, and evaluate a unique reablement service, ASSIST 2.0. The project will determine the differences in the reablement service (ASSIST 2.0) compared to regular home care in terms of older adults' performance in daily activities, self-efficacy, perceived health, quality of life, frailty and perceived person-centered approach.
The research question is: Can older adults receiving ASSIST 2.0 improve their performance and satisfaction in daily life activities, experience a higher level of self-efficacy, perceived health, quality of life and a person-centered approach?
Read more
The ASSIST project involves older adults receiving home care, home care assistants, occupational and physical therapists. ASSIST 2.0 reablement consists of the following components:
- an intervention aimed at older adults to help them perform daily activities they need and want to do. This will be achieved through optimal support from home care staff,
- an on-line education provided by the researchers for all staff in the art and science of reablement,
- training and support through mentorship and coaching provided by occupational and physical therapists for home care staff to ensure the proper delivery of reablement.
- Conditions
- Reablement, Frailty
- Being tested
- Assist Reablement (including education and mentoring)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assist Reablement (including education and mentoring)Behavioural
Reablement on-line education will be standard and mandatory for both intervention groups. Mentoring will be formed according to the pre-requisites at the site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - ASSIST intervention groups Uppsala/Stockholm | Active comparator | All staff in the intervention group will recieve an on-line reablement education. The occupational and physcial therapist in the intervention group will provide mentoring including reflection for the homecare staff. Together the team will focus on the older persons everyday occuations and deliver reablement to the older persons. Receives: Behavioral: Assist Reablement (including education and mentoring) |
| Control group Uppsala/Stockholm | No intervention | The older person will recieve home care as usual without a reablement education or support from occupational or physical therapists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of performance and/or satisfaction in prioritized everyday activities after the end of the reablement intervention, 6 and 12 months post baseline.
The Canadian Occupational Performance Measure (COPM) will be used. The COPM measures the level of self-assessed performanace and satisfaction of up to five prioritized everyday activities that the person needs, wants or is expected to do, but percieves difficulties doing them. The person rates, for each everyday activity, on a scale of 1 to 10 the prioritisation, the performance and the satisfaction of the activity. For the prioritisation 10 represents very important, one not important). For the performance scale, 10 represents the person does the activity extremely well, and one represents can not do the activity at all. For the satisfaction scale, 10 represents being extremely satisfied and and one not satisfied at all. An increase in two points or more from base-line to follow-up is a positive clinically significant difference.
Measured: Measurements will be at baseline, two weeks post base line, at the end of the intervention (6-12 weeks post baseline), 6 and 12 months post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (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 ReablementStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aileen Bergström
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Sponsor-investigator, Aileen Bergström, Karolinska Institutet
- Investigators
- Susanne Guidetti, PhD, Professor, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749080
- Sponsor's protocol ID
- ASSIST 2.0
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Assander S, Bergstrom A, Eriksson C, Meijer S, Guidetti S. ASSIST: a reablement program for older adults in Sweden - a feasibility study. BMC Geriatr. 2022 Jul 26;22(1):618. doi: 10.1186/s12877-022-03185-2.
PubMed 35879678
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSIST 2.0: a Reablement Program for Healthy Ageing
- ClinicalTrials.gov ID
- NCT06749080
- Acronym / sponsor ID
- ASSIST 2.0
- Conditions
- Reablement, Frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aileen BergströmUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Dec 2024 (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.
The goal of this study is to continue to develop, implement, and evaluate a unique reablement service, ASSIST 2.0. The project will determine the differences in the reablement service (ASSIST 2.0) compared to regular home care in terms of older adults' performance in daily activities, self-efficacy, perceived health, quality of life, frailty and perceived person-centered approach.
The research question is: Can older adults receiving ASSIST 2.0 improve their performance and satisfaction in daily life activities, experience a higher level of self-efficacy, perceived health, quality of life and a person-centered approach?
The ASSIST project involves older adults receiving home care, home care assistants, occupational and physical therapists. ASSIST 2.0 reablement consists of the following components:
- an intervention aimed at older adults to help them perform daily activities they need and want to do. This will be achieved through optimal support from home care staff,
- an on-line education provided by the researchers for all staff in the art and science of reablement,
- training and support through mentorship and coaching provided by occupational and physical therapists for home care staff to ensure the proper delivery of reablement.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - ASSIST intervention groups Uppsala/Stockholm | Active comparator | Behavioral: Assist Reablement (including education and mentoring)All staff in the intervention group will recieve an on-line reablement education. The occupational and physcial therapist in the intervention group will provide mentoring including reflection for the homecare staff. Together the team will focus on the older persons everyday occuations and deliver reablement to the older persons. |
| Control group Uppsala/Stockholm | No intervention | –The older person will recieve home care as usual without a reablement education or support from occupational or physical therapists. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Homecare has been granted
- The person can describe an ordinary day and what they have problems with doing
- 65 years of age or over
Key exclusion criteria (1 listed)
- The person has palliative care
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 |
|---|---|---|
| Assist Reablement (including education and mentoring)Reablement on-line education will be standard and mandatory for both intervention groups. Mentoring will be formed according to the pre-requisites at the site. | Behavioural | Intervention group - ASSIST intervention groups Uppsala/Stockholm |
Primary outcome
The improvement of performance and/or satisfaction in prioritized everyday activities after the end of the reablement intervention, 6 and 12 months post baseline.
Time frame: Measurements will be at baseline, two weeks post base line, at the end of the intervention (6-12 weeks post baseline), 6 and 12 months post baseline.
The Canadian Occupational Performance Measure (COPM) will be used. The COPM measures the level of self-assessed performanace and satisfaction of up to five prioritized everyday activities that the person needs, wants or is expected to do, but percieves difficulties doing them. The person rates, for each everyday activity, on a scale of 1 to 10 the prioritisation, the performance and the satisfaction of the activity. For the prioritisation 10 represents very important, one not important). For the performance scale, 10 represents the person does the activity extremely well, and one represents can not do the activity at all. For the satisfaction scale, 10 represents being extremely satisfied and and one not satisfied at all. An increase in two points or more from base-line to follow-up is a positive clinically significant difference.
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 7 Mar 2025.
- Background: PubMed 35879678Assander S, Bergstrom A, Eriksson C, Meijer S, Guidetti S. ASSIST: a reablement program for older adults in Sweden - a feasibility study. BMC Geriatr. 2022 Jul 26;22(1):618. doi: 10.1186/s12877-022-03185-2.
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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.
Susanne Assander, PhD contact
Susanne Guidetti, PhD, Professor study director
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assist Reablement (including education and mentoring) in people with Reablement and Frailty, run by Aileen Bergström at 2 sites 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 1 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Aileen L Bergström, PhD (+4673 7490139, aileen.bergstrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of performance and/or satisfaction in prioritized everyday activities after the end of the reablement intervention, 6 and 12 months post baseline. (time frame: Measurements will be at baseline, two weeks post base line, at the end of the intervention (6-12 weeks post baseline), 6 and 12 months post baseline.). 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 NCT06749080, 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 7 Mar 2025.