Clinical trial NCT04588116: Strategies Empowering Activities in Everyday Life (SEE 1.0) a Web-based Occupational Therapy Intervention
Official title: Strategies Empowering Activities in Everyday Life (SEE 1.0): a Study Protocol for a Feasibility Trial of a Web-based Occupational Therapy Intervention for People with Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke, self-management,
activities of daily life,
life-style intervention,
web-based rehabilitation,
tele-rehabilitation,
digital e- health solutions,
occupational therapy
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A feasibility study with a pre-test post-test design without control group embedded in a mix-method approach.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the feasibility and potential outcomes of a first version of a web-based intervention in occupational therapy focusing on empowering an active everyday life for people with stroke.

Detailed description: A large amount of people with stroke face extensive changes to live an active life and restrictions in engaging in various activities are common. However, the rehabilitation seldom focusses on the process of change people with stroke need to go through to adapt to their changed capacity and reach an active life on new terms. This implies that rehabilitation needs to be developed to provide activity-based self-management strategies that can facilitate an active life. Also, there is a need to improve the access to rehabilitation by making use of digital e- health solutions. Based on these needs, the web-based occupational therapy intervention "Strategies Empowering activities in Everyday life" (SEE 1.0) has been developed.

This feasibility trial has a pre-test post-test design without a control group. The trial is embedded in a mix- method approach combining assessment tools, feasibility registration forms, intervention logbooks, qualitative interviews and focus groups. The feasibility of the web-based intervention SEE as well as of the study design, will be evaluated in terms of acceptability, adherence, values and appropriateness from the perspectives of patients with stroke and the staff. Also, the potential outcome of SEE will be evaluated quantitatively and qualitatively.

The results will support the continued development of SEE and provide for larger-scale research studies. The intervention, that combines a focus on empowering an active everyday life with a web-based format including online meetings, is innovative and is not part of clinical practice today. Thereby, the results can be valuable for future research and clinical practice in general. The study protocol and the results will be published in peer-reviewed scientific journals and presented at conferences.

Eligibility criteria: Inclusion Criteria:

* Stroke
* Age: 18-75 years
* three to thirty six months after the onset of the stroke
* have moderate disability or good recovery after the stroke
* have access to a screen/computer, internet and e-ID as well as being able to use them
* experience limitations in activities in everyday life
* be motivated to participate in the program, including be ready for a process of change
* be discharged from rehabilitation at hospital or day care.

Exclusion Criteria:

* depression
* other conditions or diseases that impact on activities in everyday life
* have impairments or other diagnoses to such an extent that may have an impact on the ability to consent participation as well as participate in the data collection and intervention.

Primary outcomes:
measure: The profiles of occupational engagement (POES)
timeFrame: Change from baseline to four- and twelve-months post-base line.
measure: Occupational Balance Questionnaire (OBQ)
timeFrame: Change from baseline to four- and twelve-months post-base line
measure: Occupational values with pre-defined items (Oval-pd).
timeFrame: Change from baseline to four- and twelve-months post-base line
Secondary outcomes:
measure: Life satisfaction questionnaire (Lisat-11)
timeFrame: Change from baseline to four- and twelve-months post-base line
measure: The general self- efficacy scale (S-GSE)
timeFrame: Change from baseline to four- and twelve-months post-base line
measure: Work ability index (WAI)
timeFrame: Change from baseline to four- and twelve-months post-base line
measure: Stroke Impact Scale, participation (SIS)
timeFrame: Change from baseline to four- and twelve-months post-base line
Other outcomes:
measure: The clients' (own) experiences of adopting activity-based strategies during the intervention process of SEE and the influence of these for an active life
timeFrame: Repeatedly interviews during the intervention process, one- and fourth months post- baseline
measure: The acceptability and value of the the SEE from the perspective of the receivers
timeFrame: Four- and twelve months post- baseline
measure: The adherence of the SEE
timeFrame: During each patient's intervention process, every planned intervention occasion (according to the intervention guide), up to twelve months post-base line.
measure: The acceptability and value of the SEE from the perspective of the delivers
timeFrame: Every fourth month during the study period of two years.
Locations:
city: Luleå
country: Sweden
facility: Department of Health Science, LTU
Study officials:
affiliation: Luleå University of Technology
name: Maria A Larsson-Lund, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsson-Lund M, Mansson Lexell E, Nyman A. Strategies for Empowering activities in Everyday life (SEE 1.0): study protocol for a feasibility study of an Internet-based occupational therapy intervention for people with stroke. Pilot Feasibility Stud. 2021 Oct 16;7(1):187. doi: 10.1186/s40814-021-00924-x.