ASSIST 1.0 an Intervention Program Addressing Reablement Services

Older Adults Clinical Trial

Official title:

Evaluation of an Intervention Program Addressing Reablement Services in a Swedish Context (ASSIST 1.0) - A Protocol for a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505619
• Other study ID #: ASSIST 1.0
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 2, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Older Adults
• Participation

Intervention

Behavioral:
• ASSIST 1.0
10 weeks intervention applying a person-centred approach by using goal setting and smart products.

Locations

Country	Name	City	State
Sweden	Stockholms Äldre förvaltning	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creative Climate Questionnaire (CCQ)	Will measure the home care providers perceptions of organizational climate	Change between baseline and 8 to 10 weeks post baseline.
Other	QPS Nordic	Assessment for the home care providers psychological and social factors in the work place	Change between baseline and 8 to 10 weeks post baseline.
Other	Life Satisfaction Questionnaire (LiSat -11)	To assess life satisfaction the Life Satisfaction Scale (LiSat-11) (22) will be used. The LiSat-11contains 11 items about overall and domain-specific life satisfaction, self-rated on an ordinal scale ranging from 6 (very satisfactory) to 1 (very dissatisfactory). One global question assessing the participants' overall satisfaction with life.	Change between baseline and 8 to 10 weeks post baseline.
Other	Caregiver Burden Scale	The Caregiver Burden Scale (CBS) will be used to assess caregiver burden. The CBS consists of 22 items for different types of subjective caregiver burden, covering areas of the caregiver's health, feelings of psychological wellbeing, relations, social network, physical workload, and environmental aspects. The items are scored on a scale from 1 to 4 and the higher the score the greater the burden. The scale has been shown to have good construct validity and test-retest stability.	Change between baseline and 8 to 10 weeks post baseline.
Primary	Change in Canadian Occupational Performance Measure (COPM)	Measuring the older adults' self-perception of activity performance and satisfaction within the areas of self care, productivity and leisure, measured on a 1-10 scale, where 10 represents most satsified and highest performance ranking.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Change in Barthel Index	The Barthel Index (BI) will be administered at inclusion and post baseline will used in the present study to determine stroke severity, where scores of < 15 represented a severe stroke, 15-49 a moderate stroke, and 50-100 a mild stroke.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Frenchay Activity Index (FAI)	The FAI consist of 15 items, the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months, and ranges from 0 (inactive) to 45 (very active).	Change between baseline and 8 to 10 weeks post baseline.
Secondary	The Swedish version of the General Self -Efficacy Scale)(GSE)	Measure the perceived belief in one's ability in different situations. The GSE scale consists of ten statements such as "I can solve most problems if I invest the necessary effort." Possible responses are scored 1-4, where 1 represents "Not at all true", 2 "Hardly true", 3 "Moderately true" and 4 "Exactly true". This gives a total score ranging from 10-40; higher scores indicate a greater sense of general self-efficacy. The GSE has been translated into Swedish and has been demonstrated to be valid.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	EQ5-D	EQ5-D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Hospital Anxiety and Depression Scale (HAD)	The HADS is a screening instrument, which comprises Anxiety and Depression subscales, each with seven items and total scores ranging from 0-21. Higher scores indicate lower mood, i.e., more anxiety or depressive symptoms respectively. The recommended cut-offs for both subscales in people with stroke is =4	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Mental Health Continuum -short form, Swedish version (MHC-SF)	Measure emotional well-being, social well-being and psychological well-being.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Reintegration of Normal Living Index- (RNL)	The RNLI index is made up of 11 declarative statements (e.g. I move around my living quarters as I feel necessary), including the following domains: indoor, community, and distance mobility; self-care; daily activity (work and school); recreational and social activities;; family role(s); personal relationships; presentation of self to others and general coping skills. The first 8 items represent 'daily functioning' and the remaining 3 items represent 'perception of self'.Each domain is accompanied by a visual analogue scale (VAS) (0 to 10 cm). The VAS is anchored by the statements "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide a total score out of 110 points that is proportionally converted to create a score out of 100.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Change in Sense of Coherence	Short form measure on one's sense of health.	Change between baseline and 8 to 10 weeks post baseline.
Secondary	Change in Katz ADL extended scale	The Katz Extended Scale (KE) will be used to assess self-reported need of assistance (yes/no) in six personal ADL (PADL) and four instrumental ADL (IADL) both pre- and post-stroke.	Change between baseline and 8 to 10 weeks post baseline.