NCT06484322

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Sep 2024Jun 2027

First Submitted

Initial submission to the registry

June 20, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 17, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

June 20, 2024

Last Update Submit

September 11, 2025

Conditions

Keywords

Chronic diseaseSelf-managementActivities of daily lifeInternet-basedTele-rehabilitationE-healthOccupational therapyPreventionRehabilitationLong-term health conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Life satisfaction questionnaire (Lisat-11)

    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

  • RAND-36

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

  • General Self-Efficacy (GSE-10)

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

  • Mental Fatigue Scale (MFS)

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

  • +2 more secondary outcomes

Other Outcomes (5)

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

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

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

    Four months post-baseline

  • The adherence to SEE.

    Through intervention completion, an average of 1 year

  • +2 more other outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

The group will receive the internet-based intervention 'SEE' focusing on supporting self-management of activities in everyday life to promote health. Beside SEE, they will also receive care as usual.

Behavioral: Strategies Empowering Activities in Everyday life (SEE 2.0)

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Luleå university of technology

Luleå, None Selected, 971 87, Sweden

RECRUITING

Luleå University of Technology

Luleå, 97187, Sweden

NOT YET RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Larsson Lund, Professor

    LTU

    STUDY CHAIR

Central Study Contacts

Maria Larsson-Lund, Professor

CONTACT

Patrik Sjoeberg, Phd student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The feasibility study has been designed as a longitudinal pre-test, post test trial without a control group embedded in a mixed method approach. The participants will receive the internet-based occupational therapy intervention 'SEE'. Data from the participants will be collected at baseline (0) and 4- and 12 months post baseline.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 3, 2024

Study Start

September 10, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations