Clinical trial NCT03505619: ASSIST 1.0 an Intervention Program Addressing Reablement Services
Official title: Evaluation of an Intervention Program Addressing Reablement Services in a Swedish Context (ASSIST 1.0) - A Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Participation
Keywords: home care service
reablement service
rehabilitation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A feasibility study with a pre-post-test design.
Primary purpose: TREATMENT

Brief summary: Reablement holds a potential to become a new rehabilitation model and has been implemented in some western countries including Norway and Denmark. At present, there is a lack of scientific evidence for the effectiveness of reablement and lack of an explicit theoretical underpinning, leading to a gap in knowledge. Trends show, however, that reablement is beneficial for the person and their significant others, increasing quality of life. There is a need for further investigation of the effects among community-dwelling adults in terms of clinical and economic outcomes. This research project will investigate the effectiveness of reablement including smart products (digitally based) (ASSIST) to facilitate and manage reablement services in home-dwelling adults compared with standard home help services in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs.

Methods and analysis: This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention program as the fidelity, reach and dose, and potential outcomes by using a pre-post test design involving an intervention group and a control group (n=30). All participants will be living at home and with a need of home care services. Qualitative interviews among home care providers delivering ASSIST and older adults and their significant others receiving the intervention will be conducted to explore aspects affecting the intervention.

Ethics and dissemination: The results will form the base for refinement of the "ASSIST" program and planning of a large-scale randomized, controlled trial investigating the effect of the program on quality of life as physical health, mental well-being, conditions for social community when focusing on supporting the older person's to meaningful everyday life. Dissemination will include peer-reviewed publications and presentations at national and international conferences.


Eligibility criteria: Inclusion Criteria:

* ≥65 years or older and live at home,
* home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff,
* two or more identified challenges in everyday activities that can benefit from everyday rehabilitation,
* are able to understand and express themselves in Swedish.

Exclusion Criteria:

* have cognitive limitations that make reablement unappropriate,
* in need of care in institutional dwelling or are terminally ill ,
* the older adults have had home help services more than three years.

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
Secondary outcomes:
measure: Change in Barthel Index
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Frenchay Activity Index (FAI)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: The Swedish version of the General Self -Efficacy Scale)(GSE)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: EQ5-D
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Mental Health Continuum -short form, Swedish version (MHC-SF)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Reintegration of Normal Living Index- (RNL)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Change in Sense of Coherence
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Change in Katz ADL extended scale
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
Other outcomes:
measure: Creative Climate Questionnaire (CCQ)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: QPS Nordic
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Life Satisfaction Questionnaire (LiSat -11)
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
measure: Caregiver Burden Scale
timeFrame: Change between baseline and 8 to 10 weeks post baseline.
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Äldre förvaltning
Study officials:
affiliation: Karolinska Institutet
name: Lena Borell, professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Bergstrom A, Borell L, Meijer S, Guidetti S. Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study. BMJ Open. 2019 Jul 24;9(7):e025870. doi: 10.1136/bmjopen-2018-025870.