Strategies Empowering Activities in Everyday Life: An Internet-based Occupational Therapy Intervention
NCT Number: NCT06484322
Acronym: SEE2:0
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Disease
Interventions: BEHAVIORAL: Strategies Empowering Activities in Everyday life (SEE 2.0)
Sponsor: Luleå Tekniska Universitet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-01-01
Locations: Luleå University of Technology, Luleå, 97187, Sweden

Summary:
The purpose of the study is to evaluate the feasibility, potential outcomes and the implementation process of a second updated version of an internet-based intervention in occupational therapy, focusing on self-management in activities of everyday life to promote health in people with chronic diseases.

Primary Outcome Measures: The Satisfaction with Daily Occupation (SDO-13), Measures change in satisfaction of daily occupations through a structured interview with 13 questions within areas such as work/studies, leisure, home and self-care occupations. Satisfaction with occupations is measured on an ordinal scale with a score ranging from 0-7. The total rating range between 13-91. Higher score indicates a higher satisfaction with daily occupations., Change from baseline to four- and twelve months post-base line|Occupational Balance Questionnaire (OBQ), Measures change in perceived occupational balance; occupational balance reflects a person's subjective perception of having the right amount of- and the right variation between activities. The OBQ consist of 11 items rated on a four-point ordinal scale, scored 0 to 3. A total score may range between 0 and 33 where a higher score implies a higher sense of occupational balance., Change from baseline to four- and twelve months post-base line|Occupational values with pre-defined items (Oval-pd)., Measures change in occupational values which reflects the 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, scored 1 to 4. The responses add up to a total score between 18-72, a higher score indicates higher occupational value in the activities of everyday life., Change from baseline to four- and twelve months post-base line
Secondary Outcome Measures: Life satisfaction questionnaire (Lisat-11), Measures a change in life satisfaction. Lisat-11 consists of 11 items rated on an ordinal scale scored 1-6. A higher score indicates a higher level of life satisfaction., Change from baseline to four- and twelve months post-base line|Work ability index (WAI), Measures a change in self-perceived work ability. Self-perceived work ability is rated on a 10-point ordinal scale and a higher score indicates higher perceived work ability., Change from baseline to four- and twelve months post-base line|RAND-36, Measures change in perceived health and function in everyday life and consists of 36 items with an ordinal scale across 8 dimensions of health. The dimensions of health are graded on a scale 0-100 and a higher score indicates a higher perceived health and function in everyday life., Change from baseline to four- and twelve months post-base line|General Self-Efficacy (GSE-10), Measures change in self-reported self-efficacy which consists of 10 items on an ordinal scale from 1-4. The total score ranges from 10-40 and a higher score indicates higher self- efficacy., Change from baseline to four- and twelve months post-base line|Mental Fatigue Scale (MFS), Measures change in perceived mental fatigue and consists of 14 items rated on an ordinal scale (0-3). The summarized score ranges from 0-42. Scores over 10.5 indicate fatigue., Change from baseline to four- and twelve months post-base line|EuroQol 5 Dimensions (EQ-5D) Thermometer, Measures a change in perceived health with a score ranging from 0-100. A higher score indicates better perceived health., Change from baseline to four- and twelve months post-base line|Perceived Stress Scale (PSS), Change in perceived stress on 10 items rated on an ordinal scale (0-4). The summarised score range from 0-40. A higher score indicates a higher level of perceived stress., Change from baseline to four- and twelve months post-base line
Other Outcome Measures: The experience of people with chronic conditions participating in the intervention process of SEE., Qualitative individual open-ended interviews with client participants focusing on experiences of SEEs intervention process., Repeated interviews during the intervention process, one- and four months post-baseline|The acceptability and value of SEE from the perspective of the clients., A study specific questionnaire. The items are rated on an ordinal scale, ranging from 1 to 4. Higher scores reflect higher levels of acceptability and value of SEE., Four months post-baseline|The adherence to SEE., The adherence of SEE will be studied with a structured interview using a study specific feasibility registration form assessing whether the intervention is delivered and taken as intended. The structured individual interview based on the feasibility registration form will be conducted with the occupational therapist delivering SEE to each client., Through intervention completion, an average of 1 year|The experience of how feasibility, implementation, and context influence SEE., Experiences the feasibility and the implementation process of SEE from the perspectives of the delivers, i.e., the occupational therapists, their managers and other stakeholders/key persons will be explored qualitatively in groups interviews., Through study completion, an average of 2 year|Number of participants recruited retention and drop-out rates., The recruitment process and resulting sample will be studied by the use of study-specific registration forms., Through study completion, an average of 2 year