Strategies Empowering Activities in Everyday Life (SEE 1.0) A Web-based Occupational Therapy Intervention

Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04588116
• Other study ID #: SEE-685304
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Luleå Tekniska Universitet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Strategies Empowering activities in Everyday life (SEE 1.0)
The patients are provided a person-centered activity-based intervention on the web aiming at facilitating the level of engagement in a variety of activities, at different places in society, together with other people to support an active life. In the long-term, the change to an active life will be reflected in a healthy and balanced pattern of activities. The program provide the patients with tools to "see" their activities in everyday life in a new light and, also, tools to identify activity-based strategies that can empower them to take an active role to prevent and overcome challenging situations in everyday life.

Locations

Country	Name	City	State
Sweden	Department of Health Science, LTU	Luleå

Sponsors (1)

Lead Sponsor	Collaborator
Luleå Tekniska Universitet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The clients' (own) experiences of adopting activity-based strategies during the intervention process of SEE and the influence of these for an active life	Experiences of adopting activity-based strategies during the intervention process of the SEE and the influence of these for an active life will be explored by qualitative interviews	Repeatedly interviews during the intervention process, one- and fourth months post- baseline
Other	The acceptability and value of the the SEE from the perspective of the receivers	The acceptability and value of the SEE from the perspective of the receivers will be studied with a study specific questionnaire. The items are rated on four-graded ordinal scale, ranging from 1 to 4. Higher scores reflect higher levels of acceptability and values of the SEE.	Four- and twelve months post- baseline
Other	The adherence of the SEE	The adherence of the SEE will be studied with a study specific feasibility registration form assessing whether the intervention is delivered and taken as intended.	During each patient's intervention process, every planned intervention occasion (according to the intervention guide), up to twelve months post-base line.
Other	The acceptability and value of the SEE from the perspective of the delivers	Experiences of the SEE from the perspectives of the delivers, i.e., the occupational therapists, their managers and other stakeholders/key persons will be explored qualitatively in focus groups.	Every fourth month during the study period of two years.
Primary	The profiles of occupational engagement (POES)	Change in activity pattern/profile.The POES is based on an interview of an 24 h completed diary of time use. The nine items are scored on an ordinal scale ranging from 1 to 4. A higher score indicates a higher level of engagement in activities.	Change from baseline to four- and twelve-months post-base line.
Primary	Occupational Balance Questionnaire (OBQ)	Change in occupational balance, reflecting a person's subjective perception of having the right amount of activities and the right variation between activities. The OBQ consist of 11 items that are rated on a four-point ordinal scale, scored 0 to 3. The ratings of the OBQ are summed to a total score, ranging between 0 and 33. A higher score implies more satisfaction with the amount and variation of occupations, i.e., a higher level of occupational balance.	Change from baseline to four- and twelve-months post-base line
Primary	Occupational values with pre-defined items (Oval-pd).	Change in occupational values, reflecting a person's subjective perception of concrete, symbolic or self-rewarding values in activities. The OVal-pd consists of 18 items rated on a four-point ordinal scale with response options scored 1 to 4. The rating of the OVal-pd can be summed into a general occupational value, ranging between 18-72. .A higher score indicates that the respondent is frequently engaged in valued occupation.	Change from baseline to four- and twelve-months post-base line
Secondary	Life satisfaction questionnaire (Lisat-11)	Change in life satisfaction. The Life satisfaction questionnaire consist of 11 items rated on a six-point ordinal scale ranging from 1 to 6. A higher score reflects a higher level of satisfaction.	Change from baseline to four- and twelve-months post-base line
Secondary	The general self- efficacy scale (S-GSE)	Change in general self- efficacy. The S-GSE consist of 10 items that are rated on a four-point ordinal scale, ranging from 1 to 4. The summarized score range between 10-40. A higher score reflects greater sense of general self-efficacy.	Change from baseline to four- and twelve-months post-base line
Secondary	Work ability index (WAI)	Change in self-perceived work ability. In the WAI, self-perceived work ability is rated on a ten -point ordinal scale. A higher score reflects a higher level of perceived work ability.	Change from baseline to four- and twelve-months post-base line
Secondary	Stroke Impact Scale, participation (SIS)	Change in impact of stroke on participation is rated on a five-point ordinal scale. A higher score reflects a higher level of participation	Change from baseline to four- and twelve-months post-base line