Trial Outcomes & Findings for App-based Education and GOal-setting in Rheumatoid Arthritis (NCT NCT05888181)
NCT ID: NCT05888181
Last Updated: 2025-05-16
Results Overview
Superiority outcome. The ASES is a patient-reported questionnaire consisting of 20 items across 2 subscales: self-efficacy for managing pain (range 5-50), and self-efficacy for controlling other symptoms (range 6-60). Both scores can be summed to derive a total ASES-score (range 11-110). Higher scores indicate higher perceived self-efficacy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
At follow-up visit (4-6 months from baseline)
Results posted on
2025-05-16
Participant Flow
Of 128 enrolled participants, 122 completed the necessary baseline assessments and installed the study app. These were entered in the ITT population.
Participant milestones
| Measure |
Intervention Group A (Weekly RAID)
Access to the study app with weekly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Intervention Group B (Monthly RAID)
Access to the study app with monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
62
|
|
Overall Study
COMPLETED
|
29
|
29
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group A (Weekly RAID)
Access to the study app with weekly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Intervention Group B (Monthly RAID)
Access to the study app with monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12 • n=60 Participants
|
58 years
STANDARD_DEVIATION 11 • n=62 Participants
|
58 years
STANDARD_DEVIATION 12 • n=122 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=60 Participants
|
45 Participants
n=62 Participants
|
83 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=60 Participants
|
17 Participants
n=62 Participants
|
39 Participants
n=122 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
RF/ACPA positive
|
43 Participants
n=60 Participants
|
55 Participants
n=62 Participants
|
98 Participants
n=122 Participants
|
|
Erosive disease
|
26 Participants
n=60 Participants
|
27 Participants
n=62 Participants
|
53 Participants
n=122 Participants
|
|
Disease duration, years
|
11 years
STANDARD_DEVIATION 9 • n=60 Participants
|
13 years
STANDARD_DEVIATION 10 • n=62 Participants
|
12 years
STANDARD_DEVIATION 10 • n=122 Participants
|
|
BMI
|
26 kg/m2
STANDARD_DEVIATION 5 • n=60 Participants
|
27 kg/m2
STANDARD_DEVIATION 5 • n=62 Participants
|
27 kg/m2
STANDARD_DEVIATION 5 • n=122 Participants
|
|
Smoking ever
|
30 Participants
n=60 Participants
|
27 Participants
n=62 Participants
|
57 Participants
n=122 Participants
|
|
Rheumatic Disease Comorbidity Index (RDCI)
|
1.1 units on a scale
STANDARD_DEVIATION 1.4 • n=60 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.5 • n=62 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 1.5 • n=122 Participants
|
|
DAS28-CRP
|
2.3 units on a scale
STANDARD_DEVIATION 0.9 • n=60 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.0 • n=62 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.0 • n=122 Participants
|
|
Health Assessment Questionnaire (HAQ)
|
0.7 units on a scale
STANDARD_DEVIATION 0.7 • n=60 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.6 • n=62 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.6 • n=122 Participants
|
|
Rheumatoid Arthritis Impact of Disease (RAID)
|
3.6 units on a scale
STANDARD_DEVIATION 2.4 • n=60 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.3 • n=62 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.4 • n=122 Participants
|
|
Arthritis Self-Efficacy Scale (ASES)
|
72 units on a scale
STANDARD_DEVIATION 22 • n=60 Participants
|
72 units on a scale
STANDARD_DEVIATION 20 • n=62 Participants
|
72 units on a scale
STANDARD_DEVIATION 22 • n=122 Participants
|
|
Pain Catastrophizing Scale (PCS)
|
13 units on a scale
STANDARD_DEVIATION 11 • n=60 Participants
|
14 units on a scale
STANDARD_DEVIATION 13 • n=62 Participants
|
14 units on a scale
STANDARD_DEVIATION 13 • n=122 Participants
|
PRIMARY outcome
Timeframe: At follow-up visit (4-6 months from baseline)Superiority outcome. The ASES is a patient-reported questionnaire consisting of 20 items across 2 subscales: self-efficacy for managing pain (range 5-50), and self-efficacy for controlling other symptoms (range 6-60). Both scores can be summed to derive a total ASES-score (range 11-110). Higher scores indicate higher perceived self-efficacy.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
Arthritis Self-Efficacy Scale (ASES)
|
74 score on a scale
Standard Deviation 22
|
74 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: At follow-up visit (4-6 months from baseline)Non-inferiority outcome. The PCS comprises 13 items on a 0-4 Likert scale, resulting in a total score of 0-52 with subscales for rumination, magnification, and helplessness. Higher scores indicate more catastrophic perceptions concerning pain. Additionally, a post-hoc analysis will be carried out comparing the PCS between intervention group A and B, to study the influence of PRO-reporting frequency on pain catastrophising.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
|
11 score on a scale
Standard Deviation 8
|
13 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: At follow-up visit (4-6 months from baseline)Superiority outcome. The RAID consists of 7 items on a 0-10 numeric rating scale, enquiring about the impact of RA on pain, functional limitations, fatigue, sleep, physical wellbeing, emotional wellbeing, and coping. A total RAID score (0-10) is derived as a weighted average of the 7 subscores (Pain: 21%, Functional disability: 16%, Fatigue: 15%, Emotional well-being: 12%, Sleep: 12%, Coping: 12%, Physical well-being: 12%). Higher scores on both the total scale and the subscales indicate more perceived disease impact.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
Rheumatoid Arthritis Impact of Disease (RAID)
|
3.6 score on a scale
Standard Deviation 2.4
|
3.5 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: At follow-up visit (4-6 months from baseline)Superiority outcome. The IPAQ-S is a 7-item questionnaire enquiring about physical activities during the last 7 days. An activity score is obtained for different domains, each multiplied with the accompanying metabolic equivalent of task (MET) value, leading to a sum score corresponding with low, moderate, or high physical activity.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
International Physical Activity Questionnaire Short Form (IPAQ-S)
|
5036 MET minutes/week
Standard Deviation 3927
|
4674 MET minutes/week
Standard Deviation 4046
|
SECONDARY outcome
Timeframe: At follow-up visit (4-6 months from baseline)Superiority outcome. The PSQI measures sleep quality through 19 items across 7 domains, with a resulting total score ranging from 0-21.Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=60 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=62 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
7.5 score on a scale
Standard Deviation 3.9
|
8.0 score on a scale
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.The proportion of in-app completed RAID questionnaires will be calculated as the ratio (%) between completed questionnaires and the total number of questionnaires that were prompted throughout the study period.
Outcome measures
| Measure |
Combined Intervention Group (A & B)
n=30 Participants
Access to the study app with either weekly or monthly prompts to complete the patient-reported questionnaire Rheumatoid Arthritis Impact of Disease (RAID)
Mobile app-based self-management intervention: The self-management program, accessible via a smartphone app, comprises several components. First, the app contains an RA-specific educational program presented as videos in 16 weekly modules. Second, the app provides patients with tailored lifestyle advice, both as part of the educational program and in the form of personalized messages from a certified health coach. Third, the study app includes remote monitoring features underpinned by goal-setting principles. For instance, participants can use the app to log daily steps and physical activity, as well as their diet, sleep, and mental health. Personal goals, as well as physical challenges and meditation or mindfulness exercises, can be set up within the app to encourage behavioral change.
Finally, patient-reported disease burden can be monitored within the study app via the RAID instrument. Based on random allocation to one of both intervention groups, the RAID will be prompted either weekly (group A) or monthly (group B).
|
Control Group (Usual Care)
n=30 Participants
No access to the study app, follow-up according to usual care standards. This includes informal screening for general wellbeing during outpatient clinic visits, with referral to specific allied health professionals for additional education or non-pharmacological support if needed. The scores derived from study-related questionnaires can be used as a guide for these discussions. As part of standard care, participants in both the control group and the intervention groups will also receive a standardised educational leaflet about RA.
|
|---|---|---|
|
Participant Engagement With Study Application: Remote Monitoring of RAID
|
47 percentage completed RAIDs
|
53 percentage completed RAIDs
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.Usage data will be logged passively in the study app. Usage data consist of information concerning how often the app and its core functions are accessed. Specifically, we will calculate the proportion of days where the study app was accessed, and the proportion of days where an educational video was viewed within the study app.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study period (intervention arms only): 4-6 months. Specifically, these data will be collected at the follow-up visit (4-6 months from baseline) and reported for the whole study period.When users choose to activate this function, the number of steps per day will also be passively logged in the study app. When available, we will analyze daily step patterns descriptively (proportion meeting the WHO-recommended daily target, evolution over time, correlation with IPAQ-S score, and correlation with symptoms based on the RAID).
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group A (Weekly RAID)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group B (Monthly RAID)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place