NCT06749080

Brief 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, 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2025Sep 2028

First Submitted

Initial submission to the registry

December 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

December 19, 2024

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

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.

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.

Interventions

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.

Intervention group - ASSIST intervention groups Uppsala/Stockholm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Homecare has been granted
  • The person can describe an ordinary day and what they have problems with doing
  • years of age or over

You may not qualify if:

  • The person has palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska Institutet

Huddinge, Sweden, 181 83, Sweden

ACTIVE NOT RECRUITING

Uppsala Kommun

Uppsala, Sweden, 753 75, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35879678BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susanne Guidetti, PhD, Professor

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

Aileen L Bergström, PhD

CONTACT

Susanne Assander, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Ass. Lecturer

Study Record Dates

First Submitted

December 19, 2024

First Posted

December 27, 2024

Study Start

February 3, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

March 7, 2025

Record last verified: 2025-03

Locations