Strategies Empowering Activities in Everyday Life: An Internet-based Occupational Therapy Intervention (SEE2:0)

Strategies Empowering Activities in Everyday Life (SEE 2.0); A Feasibility Evaluation of 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Strategies Empowering Activities in Everyday life (SEE 2.0)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Larsson-Lund, Professor; Phone Number: +46 +0046- 920-493833; Email: maria.larsson-lund@ltu.se
• Study Contact Backup: Name: Patrik Sjoeberg, Phd student; Phone Number: +46 0920-49 21 15; Email: patrik.sjoberg@ltu.se

Study Locations

• Sweden
  • Luleå, Sweden, 97187
    • Not yet recruiting
    • Luleå University of Technology
    • Contact: Maria Larsson-Lund, Professor; Phone Number: +46 0920-49 38 33; Email: maria.larsson-lund@ltu.se
    • Contact: Patrik Sjoeberg, Phd student; Phone Number: +46 076-126 76 85; Email: Patrik.sjoberg@ltu.se
    • Principal Investigator: Maria Larsson-Lund, Professor
  • None Selected
    • Luleå, None Selected, Sweden, 971 87
      • Recruiting
      • Luleå University of Technology
      • Contact: Maria, Professor; Phone Number: 0702827533; Email: Maria.Larsson-Lund@ltu.se
      • Contact: Asa Lindback, Administrator; Phone Number: 0920-493806; Email: asa.lindback@ltu.se
      • Sub-Investigator: Patrik Sjöberg, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Luleå Tekniska Universitet
• Investigators: Study Chair: Maria Larsson Lund, Professor, LTU

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Prevention; Occupational therapy; Self-management; E-health; Chronic disease; Tele-rehabilitation; Internet-based; Activities of daily life; Long-term health conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease
• Other Study ID Numbers: SEE-633 940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No