Chronic DiseaseNCT03437863
Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
A study testing Mobile application in people with Chronic Disease and Rheumatic Diseases, run by Oslo University Hospital at 1 site in Norway.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Rheumatic Diseases
- What is being tested?
- Mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 18 Apr 2018to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease, Rheumatic Diseases
- Being tested
- Mobile application
- Keywords
- self-management, health assets, Strengths, mHealth, Feasibility
- Medical subject headings
- Chronic Disease, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | 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. Receives: Device: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Usefulness of the Application
Study-specific questions on perceived usefulness of the application
Measured: Within an hour after using 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.
Measured: Within an hour after using the application
Secondary outcomes (2)
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.
Measured: Pre-intervention and post-intervention, within an hour after using the application
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.
Measured: Pre-intervention and post-intervention, within an hour after using the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start18 Apr 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be recruited to a pre-post design study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Elin Borosund, Oslo University Hospital
- Investigators
- Olöf B Kristjansdottir, PhD, Principal investigator, Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437863
- Sponsor's protocol ID
- 2015065
- Status last verified
- Nov 2021
- First submitted
- 13 Feb 2018
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capitalizing on the Strengths of Persons With Rheumatoid Arthritis to Improve Health and Wellness
- ClinicalTrials.gov ID
- NCT03437863
- Acronym / sponsor ID
- 2015065
- Conditions
- Chronic Disease, Rheumatic Diseases
- Keywords
- self-management, health assets, Strengths, mHealth, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Diakonhjemmet Hospital
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 16 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be recruited to a pre-post design study.
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Device: Mobile applicationParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationUse 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. | Device | Mobile application |
Primary outcome
Perceived Usefulness of the Application
Time frame: Within an hour after using the application
Study-specific questions on perceived usefulness of the application
The System Usability Scale
Time frame: Within an hour after using the application
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.
2 secondary outcomes
The Positive and Negative Affect Schedule.
Time frame: Pre-intervention and post-intervention, within an hour after using the application
The Arthritis Self-efficacy Scale
Time frame: Pre-intervention and post-intervention, within an hour after using the application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olöf B Kristjansdottir, PhD principal investigator
Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Chronic Disease and Rheumatic Diseases, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Usefulness of the Application (time frame: Within an hour after using the application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.