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Completed

NCT Number: NCT04588116

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Science, LTU

Luleå, 97187, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strategies Empowering activities in Everyday life (SEE 1.0)

Behavioral

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.

Other names: Strategies Empowering activities in Everyday life (SEE 1.0) A web-based occupational therapy intervention for people with stroke

Primary outcomes

  1. The profiles of occupational engagement (POES)

    Time frame: Change from baseline to four- and twelve-months post-base line.

    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.

  2. Occupational Balance Questionnaire (OBQ)

    Time frame: Change from baseline to four- and twelve-months post-base line

    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.

  3. Occupational values with pre-defined items (Oval-pd).

    Time frame: Change from baseline to four- and twelve-months post-base line

    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.

Secondary outcomes

  1. Life satisfaction questionnaire (Lisat-11)

    Time frame: Change from baseline to four- and twelve-months post-base line

    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.

  2. The general self- efficacy scale (S-GSE)

    Time frame: Change from baseline to four- and twelve-months post-base line

    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.

  3. Work ability index (WAI)

    Time frame: Change from baseline to four- and twelve-months post-base line

    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.

  4. Stroke Impact Scale, participation (SIS)

    Time frame: Change from baseline to four- and twelve-months post-base line

    Change in impact of stroke on participation is rated on a five-point ordinal scale. A higher score reflects a higher level of participation

Other outcomes

  1. The clients' (own) experiences of adopting activity-based strategies during the intervention process of SEE and the influence of these for an active life

    Time frame: Repeatedly interviews during the intervention process, one- and fourth months post- baseline

    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

  2. The acceptability and value of the the SEE from the perspective of the receivers

    Time frame: Four- and twelve months post- baseline

    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.

  3. The adherence of the SEE

    Time frame: During each patient's intervention process, every planned intervention occasion (according to the intervention guide), up to twelve months post-base line.

    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.

  4. The acceptability and value of the SEE from the perspective of the delivers

    Time frame: Every fourth month during the study period of two years.

    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.

Sponsors and collaborators

Lead sponsor

Luleå Tekniska Universitet

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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