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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Occupational values with pre-defined items (Oval-pd).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The web- based occupational therapy intervention SEE
The web-based intervention starts with eight educational modules focusing on engagement in activities and strategies to support an active life. The modules, that is delivered on a secure national health platform, include short education videos followed by self-reflections and digital assignments supporting the change process. The occupational therapist provides feedback after each assignment and, also, meet the patients for face- to- face online guiding sessions at three times during these first two- three weeks of the intervention. Thereafter, an individually tailored activity plan with goals and activity-based strategies are established. During the change process, the patients receive continued support from the occupational therapist until the goals are achieved.
干预措施: Strategies Empowering activities in Everyday life (SEE 1.0) (Behavioral)
结局指标
主要结局
Occupational values with pre-defined items (Oval-pd).
时间窗: 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.
Occupational Balance Questionnaire (OBQ)
时间窗: 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.
The profiles of occupational engagement (POES)
时间窗: 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.
次要结局
- The general self- efficacy scale (S-GSE)(Change from baseline to four- and twelve-months post-base line)
- Life satisfaction questionnaire (Lisat-11)(Change from baseline to four- and twelve-months post-base line)
- Stroke Impact Scale, participation (SIS)(Change from baseline to four- and twelve-months post-base line)
- Work ability index (WAI)(Change from baseline to four- and twelve-months post-base line)
研究者
Maria Larsson Lund
Chaired Professor
Luleå Tekniska Universitet