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NCT Number: NCT06484322

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

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.

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luleå university of technology, Luleå, None Selected, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Strategies Empowering Activities in Everyday life (SEE 2.0)

Behavioral

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 knowledge of how strategies and changes in daily activities can prevent disabilities and contribute to improved health. After that, the focus is on establishing an activity plan with goals and activity-based management strategies to promote an active everyday life. The clients' implementation of the plan is supported through follow-up meetings. During the whole intervention process, the client is regularly supported by an occupational therapist through feedback and online guiding dialogues.

Primary outcomes

  1. The Satisfaction with Daily Occupation (SDO-13)

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

    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.

  2. Occupational Balance Questionnaire (OBQ)

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

    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.

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

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

    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.

Secondary outcomes

  1. Life satisfaction questionnaire (Lisat-11)

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

    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.

  2. Work ability index (WAI)

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

    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.

  3. RAND-36

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

    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.

  4. General Self-Efficacy (GSE-10)

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

    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.

  5. Mental Fatigue Scale (MFS)

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

    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.

  6. EuroQol 5 Dimensions (EQ-5D) Thermometer

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

    Measures a change in perceived health with a score ranging from 0-100. A higher score indicates better perceived health.

  7. Perceived Stress Scale (PSS)

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

    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.

Other outcomes

  1. The experience of people with chronic conditions participating in the intervention process of SEE.

    Time frame: Repeated interviews during the intervention process, one- and four months post-baseline

    Qualitative individual open-ended interviews with client participants focusing on experiences of SEEs intervention process.

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

    Time frame: Four months post-baseline

    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.

  3. The adherence to SEE.

    Time frame: Through intervention completion, an average of 1 year

    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.

  4. The experience of how feasibility, implementation, and context influence SEE.

    Time frame: Through study completion, an average of 2 year

    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.

  5. Number of participants recruited retention and drop-out rates.

    Time frame: Through study completion, an average of 2 year

    The recruitment process and resulting sample will be studied by the use of study-specific registration forms.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Larsson-Lund, Professor

CONTACT

[email protected]

+0046- 920-493833 ext. +46

Patrik Sjoeberg, Phd student

CONTACT

[email protected]

0920-49 21 15 ext. +46

Sponsors and collaborators

Lead sponsor

Luleå Tekniska Universitet

Other

Registry information

Official study title

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

Acronym: SEE2:0

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Sep 17, 2025

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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