Clinical trial NCT06484322: Strategies Empowering Activities in Everyday Life: An Internet-based Occupational Therapy Intervention
Official title: Strategies Empowering Activities in Everyday Life (SEE 2.0); A Feasibility Evaluation of an Internet-based Occupational Therapy Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic disease
Self-management
Activities of daily life
Internet-based
Tele-rehabilitation
E-health
Occupational therapy
Prevention
Rehabilitation
Long-term health conditions
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 40
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: The feasibility study has been designed as a longitudinal pre-test, post test trial without a control group embedded in a mixed method approach. Using a predefined block randomization the participants will be randomly distributed to either the experimental/ intervention group or the control group. The experimental group will receive the internet-based occupational therapy intervention 'SEE' and the control group will receive care as usual.

Data from the participants will be collected at baseline (0) and 4- and 12 months post baseline.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The number of people with chronic disease is increasing as is the need of preventive efforts to facilitate their health. Chronic diseases are defined as 'long-term health conditions' that require constant attention and/or limit activities of daily living. People living with one or multiple chronic diseases experience difficulties to live an active everyday life and restrictions of engagement in various activities are common. Interventions that support their process of change and development of self-management in everyday life in relation to their changed capacity needs to be established. Research shows that the access to interventions is facilitated by the use of internet-based solutions. Hence, an internet-based occupational therapy intervention 'Strategies Empowering activities in Everyday life' (SEE) has been developed that will be evaluated in a feasibility trial.

The feasibility study is designed as a longitudinal trial with pre-test, post test evaluation without control group embedded in a mixed method approach. Data will be collected by assessment tools, qualitative interviews and group interviews. Evaluation of the feasibility of the intervention and the study design will be conducted in terms of acceptability, adherence, values, and implementation, from the perspective of patients with chronic disease and health care personnel at different organizational levels in the primary care.

The results from this feasibility study will support the continued development of SEE in future larger-scale evaluation studies. The goal is that SEE will add to existing interventions and becomes implemented in clinical practice. The results will be published in peer-reviewed scientific journals and presented at conferences.

Eligibility criteria: Inclusion Criteria:

* Diagnosed or at risk of developing a chronic disease/long-term condition such as long-term pain, stress-related conditions, neurological diseases and chronic fatigue syndrome
* Age: 18-75 years
* Experiencing difficulties to have an active everyday life and/or experiencing a need to develop self-management strategies in everyday life.
* Have access to a screen/computer, internet and e-ID as well as being able to use them
* Be able to participate in the program, including be ready for a process of change
* Understanding of the Swedish language in written and oral form.

Exclusion Criteria:

* Sickness or disease which causes difficulties with understanding written and verbal advice (e.g. mental or cognitive illness).
* Having an ongoing misuse
* Receiving palliative care

Primary outcomes:
measure: The Satisfaction with Daily Occupation (SDO-13)
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: Work ability index (WAI)
timeFrame: Change from baseline to four- and twelve months post-base line
measure: RAND-36
timeFrame: Change from baseline to four- and twelve months post-base line
measure: General Self-Efficacy (GSE-10)
timeFrame: Change from baseline to four- and twelve months post-base line
measure: Mental Fatigue Scale (MFS)
timeFrame: Change from baseline to four- and twelve months post-base line
measure: EuroQol 5 Dimensions (EQ-5D) Thermometer
timeFrame: Change from baseline to four- and twelve months post-base line
measure: Perceived Stress Scale (PSS)
timeFrame: Change from baseline to four- and twelve months post-base line
Other outcomes:
measure: The experience of people with chronic conditions participating in the intervention process of SEE.
timeFrame: Repeated interviews during the intervention process, one- and four months post-baseline
measure: The acceptability and value of SEE from the perspective of the clients.
timeFrame: Four months post-baseline
measure: The adherence to SEE.
timeFrame: Through intervention completion, an average of 1 year
measure: The experience of how feasibility, implementation, and context influence SEE.
timeFrame: Through study completion, an average of 2 year
measure: Number of participants recruited retention and drop-out rates.
timeFrame: Through study completion, an average of 2 year
Locations:
city: Lulea
country: Sweden
facility: Luleå university of technology
state: None Selected
city: Luleå
country: Sweden
facility: Luleå University of Technology
Study officials:
affiliation: LTU
name: Maria Larsson Lund, Professor
role: STUDY_CHAIR
References: