- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437863
Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
November 15, 2021 updated by: Elin Borosund, Oslo University Hospital
Capitalizing on the Strengths of Persons With Rheumatoid Arthritis to Improve Health and Wellness
Self-management of chronic illness can be highly demanding and people need to mobilize their personal strengths in order to live well with their condition.
A mobile application was designed in collaboration with people with chronic illness and health care providers with the aims to support awareness of patients' strengths and patient-provider dialogues that include strengths.
The aim of the present study is to evaluate with mixed methods the perceived usefulness and usability of the application and potential effects of the application on patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this pre-post design pilot study participants will be recruited from self-management courses for people with rheumatic diseases.
Before using the application participants will be asked to report their strengths in a written format.
After using the mobile application to reflect on their strengths the participants will be interviewed about their experience of using the application and on the task of reflecting on their strengths.
They will also be asked to fill out a questionnaire on perceived usefulness and user-friendliness.
Before and after using the application the participants fill out questionnaires on emotions (Positive and Negative Affective Scale) and self-efficacy (The Arthritis Self-efficacy Scale).
All interviews will be audio-taped and analyzed with a qualitative approach.
Descriptive analysis will be applied for quantitative data.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0370
- Diakonhjemmet Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Setting 1:
Inclusion Criteria:
- Age of 18 years or older
- Can read and speak Norwegian language
- Diagnosed with a chronic condition
- Participating or having recently participated in a learning and mastery or an outpatient rehabilitation program
No exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile application
Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths.
The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.
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Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Usefulness of the Application
Time Frame: Within an hour after using the application
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Study-specific questions on perceived usefulness of the application
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Within an hour after using the application
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The System Usability Scale
Time Frame: Within an hour after using the application
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This 10 item questionnaire measures usability.
Each item has 5 response options with total score ranging from 0 to 100.
Higher values represent a better outcome.
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Within an hour after using the application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Positive and Negative Affect Schedule.
Time Frame: Pre-intervention and post-intervention, within an hour after using the application
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This scale measures positive and negative affect with two subscales (positive affect and negative affect).
Positive affect subscale scores can range from 10-50, with higher scores representing higher levels of positive affect.
Negative affect subscale scores can range from 10-50, with lower scores representing lower levels of negative affect.
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Pre-intervention and post-intervention, within an hour after using the application
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The Arthritis Self-efficacy Scale
Time Frame: Pre-intervention and post-intervention, within an hour after using the application
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This scale measures self-efficacy with two subscales with 5 response options.
The "pain" subscale has 5 items and a score range from 0 to 20.
The "other symptoms" subscale has 6 items and a score range from 0 to 24.
Higher scores equal higher levels of self-efficacy.
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Pre-intervention and post-intervention, within an hour after using the application
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olöf B Kristjansdottir, PhD, Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2018
Primary Completion (Actual)
September 20, 2018
Study Completion (Actual)
September 20, 2018
Study Registration Dates
First Submitted
February 13, 2018
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015065
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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