CClinicalTrials.gg
CompletedNCT03437863Updated Nov 16, 2021Results posted

Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness

An interventional study of Mobile application in Chronic Disease and Rheumatic Diseases, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Chronic Disease
  • Rheumatic Diseases

Keywords

  • self-management
  • health assets
  • Strengths
  • mHealth
  • Feasibility
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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.

    Device: Mobile application

Interventions

  • DeviceMobile application

    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.

05

What researchers measure

Primary outcomes

  1. Perceived Usefulness of the Application

    Study-specific questions on perceived usefulness of the application

    Time frame: Within an hour after using the application

  2. 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.

    Time frame: Within an hour after using the application

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention and post-intervention, within an hour after using the application

  2. 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.

    Time frame: Pre-intervention and post-intervention, within an hour after using the application

06

Results

Posted Nov 16, 2021

Participant flow

Participant flow — Overall Study
MilestoneMobile Application
Started12
Completed12
Not completed0

Outcome measures

PrimaryPerceived Usefulness of the Application

Study-specific questions on perceived usefulness of the application

Time frame:
Within an hour after using the application
Reported as:
Count of participants · Participants
Perceived Usefulness of the Application
ParticipantsMobile Application
It was meaningful and relevant to use the app — Agree or strongly agree12
It was meaningful and relevant to use the app — Disagree or strongly disagree0
It was meaningful and relevant to use the app — Neutral0
It was meaningful and relevant to use the app — Mssing0
I became more aware of my own strengths by using the app — Agree or strongly agree9
I became more aware of my own strengths by using the app — Disagree or strongly disagree1
I became more aware of my own strengths by using the app — Neutral2
I became more aware of my own strengths by using the app — Mssing0
It was useful for me to see an overview of my own strengths — Agree or strongly agree10
It was useful for me to see an overview of my own strengths — Disagree or strongly disagree0
It was useful for me to see an overview of my own strengths — Neutral2
It was useful for me to see an overview of my own strengths — Mssing0
It was useful for me to be able to register a goal — Agree or strongly agree5
It was useful for me to be able to register a goal — Disagree or strongly disagree2
It was useful for me to be able to register a goal — Neutral4
It was useful for me to be able to register a goal — Mssing1
It was useful for me to be able to link the strengths to concrete goals — Agree or strongly agree6
It was useful for me to be able to link the strengths to concrete goals — Disagree or strongly disagree0
It was useful for me to be able to link the strengths to concrete goals — Neutral5
It was useful for me to be able to link the strengths to concrete goals — Mssing1
I liked the possibility to register my own notes — Agree or strongly agree7
I liked the possibility to register my own notes — Disagree or strongly disagree0
I liked the possibility to register my own notes — Neutral4
I liked the possibility to register my own notes — Mssing1
For me it would be relevant to share the overview of my strengths with my healthcare provider — Agree or strongly agree8
For me it would be relevant to share the overview of my strengths with my healthcare provider — Disagree or strongly disagree0
For me it would be relevant to share the overview of my strengths with my healthcare provider — Neutral4
For me it would be relevant to share the overview of my strengths with my healthcare provider — Mssing0
It was boring to use the app — Agree or strongly agree2
It was boring to use the app — Disagree or strongly disagree9
It was boring to use the app — Neutral1
It was boring to use the app — Mssing0
It was demanding for me to use the app — Agree or strongly agree1
It was demanding for me to use the app — Disagree or strongly disagree11
It was demanding for me to use the app — Neutral0
It was demanding for me to use the app — Mssing0
I would like to have the app on my own mobile devise — Agree or strongly agree7
I would like to have the app on my own mobile devise — Disagree or strongly disagree2
I would like to have the app on my own mobile devise — Neutral3
I would like to have the app on my own mobile devise — Mssing0
I would recommend the app to others in my situation — Agree or strongly agree9
I would recommend the app to others in my situation — Disagree or strongly disagree0
I would recommend the app to others in my situation — Neutral3
I would recommend the app to others in my situation — Mssing0
PrimaryThe 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.

Time frame:
Within an hour after using the application
Reported as:
Median · score on a scale
The System Usability Scale
score on a scaleMobile Application
The System Usability Scale86.3 (70 to 100)
SecondaryThe 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.

Time frame:
Pre-intervention and post-intervention, within an hour after using the application
Reported as:
Median · score on a scale
The Positive and Negative Affect Schedule.
score on a scaleMobile Application
Positive emotion sub scale (pre-intervention)34.0 (31.0 to 46.0)
Positive emotion sub scale (post-intervention)35.0 (28.0 to 45.0)
Negative emotion subscale (pre-intervention)12.0 (10.0 to 23.0)
Negative emotion (post-intervention)11.0 (10.0 to 16.0)
SecondaryThe 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.

Time frame:
Pre-intervention and post-intervention, within an hour after using the application
Reported as:
Median · score on a scale
The Arthritis Self-efficacy Scale
score on a scaleMobile Application
Pain sub scale (pre-intervention)12.0 (5.0 to 16.0)
Pain sub scale (post-intervention)14.0 (6.0 to 17.0)
Other symptoms sub scale (pre-intervention)16.0 (8.0 to 22.0)
Other symptoms subscale (post-intervention)17.0 (10.0 to 22.0)

Adverse events

Collected over Within about 1 hour from testing the application.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mobile Application0/12 (0%)0/12 (0%)0/12 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mobile Application
Median50.0 (30 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)Mobile Application
Female11
Male1
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Mobile Application
07

Study locations

1 site
  • Diakonhjemmet Hospital
    Oslo, 0370, Norway
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 19, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03437863
Lead sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Diakonhjemmet Hospital
Responsible party
Elin Borosund (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Feb 19, 2018
Start date
Apr 18, 2018
Primary completion
Sep 20, 2018
Completion
Sep 20, 2018
Results posted
Nov 16, 2021
Last update
Nov 16, 2021

Study contacts

Olöf B Kristjansdottir, PhD
principal investigator · Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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