- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06749080
ASSIST 2.0: a Reablement Program for Healthy Ageing
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aileen L Bergström, PhD
- Phone Number: +4673 7490139
- Email: aileen.bergstrom@ki.se
Study Contact Backup
- Name: Susanne Assander, PhD
- Email: susanne.assander@uu.se
Study Locations
-
-
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Huddinge, Sweden, 181 83
- Active, not recruiting
- Karolinska Institutet
-
Uppsala, Sweden, 753 75
- Recruiting
- Uppsala kommun
-
Contact:
- Kajsa Rosen, Physical Therapist (MAR)
- Phone Number: +46 18-727 84 48
- Email: kajsa.rosen@uppsala.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Homecare has been granted
- The person can describe an ordinary day and what they have problems with doing
- 65 years of age or over
Exclusion criteria:
• The person has palliative care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention group - ASSIST intervention groups Uppsala/Stockholm
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.
|
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.
|
|
No Intervention: Control group Uppsala/Stockholm
The older person will recieve home care as usual without a reablement education or support from occupational or physical therapists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Susanne Guidetti, PhD, Professor, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASSIST 2.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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