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Recruiting NCT06484322

Strategies Empowering Activities in Everyday Life: An Internet-based Occupational Therapy Intervention

No phase Interventional Chronic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Strategies Empowering Activities in Everyday life (SEE 2.0).
Who it may be relevant to
Registry conditions: Chronic Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Strategies Empowering Activities in Everyday Life (SEE 2.0); A Feasibility Evaluation of an Internet-based Occupational Therapy Intervention

Overview

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 primary care, as well as in out-patient and in-patient care at a regional hospital.

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.

Interventions

  • Behavioral Strategies Empowering Activities in Everyday life (SEE 2.0)
    SEEs internet-based intervention process begins with supporting the client to explore the need of and readiness for changes in everyday life. Thereafter, the client is supported to self-analyse their engagement in activities in everyday life along with use of management strategies in everyday life. Next, the client takes on web- modules including short educational movies with subsequent analyses and reflections. The modules aim to support the development of self-management by improving the knowl

Primary outcome measures

  • The Satisfaction with Daily Occupation (SDO-13) [Time frame: Change from baseline to four- and twelve months post-base line]
  • Occupational Balance Questionnaire (OBQ) [Time frame: Change from baseline to four- and twelve months post-base line]
  • Occupational values with pre-defined items (Oval-pd). [Time frame: Change from baseline to four- and twelve months post-base line]
Secondary outcome measures (7)
  • Life satisfaction questionnaire (Lisat-11) [Time frame: Change from baseline to four- and twelve months post-base line]
  • Work ability index (WAI) [Time frame: Change from baseline to four- and twelve months post-base line]
  • RAND-36 [Time frame: Change from baseline to four- and twelve months post-base line]
  • General Self-Efficacy (GSE-10) [Time frame: Change from baseline to four- and twelve months post-base line]
  • Mental Fatigue Scale (MFS) [Time frame: Change from baseline to four- and twelve months post-base line]
  • EuroQol 5 Dimensions (EQ-5D) Thermometer [Time frame: Change from baseline to four- and twelve months post-base line]
  • Perceived Stress Scale (PSS) [Time frame: Change from baseline to four- and twelve months post-base line]

Eligibility criteria

Inclusion criteria

  • Diagnosed with, or at risk of developing, a chronic disease/long-term condition such as long-term pain, stress-related conditions, chronic fatigue syndrome, rheumatological diseases, lung diseases, or neurological conditions.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 2 centers
  • Luleå university of technology — Luleå
  • Luleå University of Technology — Luleå

Publications

  • Larsson-Lund M, Karlsson Sundbaum J, Mansson Lexell E, Spinord L. Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life' (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol. BMJ Open. 2025 Oct 21;15(10):e102026. doi: 10.1136/bmjopen-2025-102026. PMID 41125291

Identifiers

NCT: NCT06484322 · SEE-633 940

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗