Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
Primary Purpose
Chronic Disease, Rheumatic Diseases
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Mobile application
Sponsored by
About this trial
This is an interventional device feasibility trial for Chronic Disease focused on measuring self-management, health assets, Strengths, mHealth, Feasibility
Eligibility Criteria
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
Sites / Locations
- Diakonhjemmet Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile application
Arm Description
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.
Outcomes
Primary Outcome Measures
Perceived Usefulness of the Application
Study-specific questions on perceived usefulness of the application
The System Usability Scale
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.
Secondary Outcome Measures
The Positive and Negative Affect Schedule.
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.
The Arthritis Self-efficacy Scale
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.
Full Information
NCT ID
NCT03437863
First Posted
February 13, 2018
Last Updated
November 15, 2021
Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Diakonhjemmet Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03437863
Brief Title
Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
Official Title
Capitalizing on the Strengths of Persons With Rheumatoid Arthritis to Improve Health and Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Diakonhjemmet Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Rheumatic Diseases
Keywords
self-management, health assets, Strengths, mHealth, Feasibility
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be recruited to a pre-post design study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived Usefulness of the Application
Description
Study-specific questions on perceived usefulness of the application
Time Frame
Within an hour after using the application
Title
The System Usability Scale
Description
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.
Time Frame
Within an hour after using the application
Secondary Outcome Measure Information:
Title
The Positive and Negative Affect Schedule.
Description
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.
Time Frame
Pre-intervention and post-intervention, within an hour after using the application
Title
The Arthritis Self-efficacy Scale
Description
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.
Time Frame
Pre-intervention and post-intervention, within an hour after using the application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olöf B Kristjansdottir, PhD
Organizational Affiliation
Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0370
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
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