App-based Education and GOal-setting in Rheumatoid Arthritis

Effectiveness and Feasibility of a Mobile Health Self-management Intervention for Patients With Rheumatoid Arthritis: the App-based Education and GOal-setting in Rheumatoid Arthritis Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05888181

Acronym

AEGORA

Enrollment

128

Registered

2023-06-05

Start date

2023-03-03

Completion date

2024-02-29

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

self-management, mobile health, smartphone applications, education, patient-reported outcomes, lifestyle, goal-setting, remote monitoring

Brief summary

The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid arthritis (RA), aiming to improve self-efficacy for the management of RA-related symptoms. The intervention consists of education, lifestyle advice and remote monitoring elements and is based on principles of goal setting, self-efficacy theory and behavioural economics, embedded within a platform supported by motivational features and gamification. The primary endpoint is defined as achieving at least a minimal clinically important difference in arthritis-related self-efficacy (the ASES-score) at the follow-up visit in favour of the intervention group when compared to the control group. Moreover, although qualitative studies have highlighted concerns among both patients and healthcare professionals that mobile apps might induce illness behaviour by increasing patients' awareness of their symptoms, this has rarely been studied in detail. Consequently, data regarding the effects of remote monitoring on symptom hypervigilance remain limited and conflicting. Therefore, this trial additionally aims to assess (as a key secondary objective) if a mobile app-based intervention is associated with changes in pain catastrophising, as a conceptualisation of hypervigilance to symptoms.

Interventions

OTHERMobile 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients will be considered eligible for participation in the study if they: * Are able and willing to provide written informed consent for participation. * Are 18 years of age or older. * Have a diagnosis of RA made by a rheumatologist, with a minimal time since diagnosis of 16 weeks. This time frame was chosen based on conceptual reasons and previous work of our research group, suggesting that the dynamic and impactful first weeks after diagnosis are not the ideal time window to assess psychosocial outcomes. * Are able to understand and read Dutch. * Have access to a smartphone that meets the technical requirements to run the study application, including an Android (8.0 or more recent) or Apple iOS (14.0 or more recent) operating system, and feel comfortable using it. In order to include an optimally representative patient population, no additional

Exclusion criteria

will be applied for this study.

Design outcomes

Primary

Measure	Time frame	Description
Arthritis Self-Efficacy Scale (ASES)	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.

Secondary

Measure	Time frame	Description
Rheumatoid Arthritis Impact of Disease (RAID)	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.
Pain Catastrophizing Scale (PCS)	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.
International Physical Activity Questionnaire Short Form (IPAQ-S)	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.
Pittsburgh Sleep Quality Index (PSQI)	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.

Other

Measure	Time frame	Description
Participant Engagement With Study Application: Daily Step Count	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).
Participant Engagement With Study Application: Usage of the App	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.
Participant Engagement With Study Application: Remote Monitoring of RAID	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.

Countries

Belgium

Participant flow

Pre-assignment details

Of 128 enrolled participants, 122 completed the necessary baseline assessments and installed the study app. These were entered in the ITT population.

Participants by arm

Arm	Count
Combined Intervention Group (A & B) 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).	60
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.	62
Total	122

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	1	0

Baseline characteristics

Characteristic	Combined Intervention Group (A & B)	Control Group (Usual Care)	Total
Age, Continuous	58 years STANDARD_DEVIATION 12	58 years STANDARD_DEVIATION 11	58 years STANDARD_DEVIATION 12
Arthritis Self-Efficacy Scale (ASES)	72 units on a scale STANDARD_DEVIATION 22	72 units on a scale STANDARD_DEVIATION 20	72 units on a scale STANDARD_DEVIATION 22
BMI	26 kg/m2 STANDARD_DEVIATION 5	27 kg/m2 STANDARD_DEVIATION 5	27 kg/m2 STANDARD_DEVIATION 5
DAS28-CRP	2.3 units on a scale STANDARD_DEVIATION 0.9	2.4 units on a scale STANDARD_DEVIATION 1	2.4 units on a scale STANDARD_DEVIATION 1
Disease duration, years	11 years STANDARD_DEVIATION 9	13 years STANDARD_DEVIATION 10	12 years STANDARD_DEVIATION 10
Erosive disease	26 Participants	27 Participants	53 Participants
Health Assessment Questionnaire (HAQ)	0.7 units on a scale STANDARD_DEVIATION 0.7	0.6 units on a scale STANDARD_DEVIATION 0.6	0.6 units on a scale STANDARD_DEVIATION 0.6
Pain Catastrophizing Scale (PCS)	13 units on a scale STANDARD_DEVIATION 11	14 units on a scale STANDARD_DEVIATION 13	14 units on a scale STANDARD_DEVIATION 13
Race and Ethnicity Not Collected	—	—	0 Participants
RF/ACPA positive	43 Participants	55 Participants	98 Participants
Rheumatic Disease Comorbidity Index (RDCI)	1.1 units on a scale STANDARD_DEVIATION 1.4	1.5 units on a scale STANDARD_DEVIATION 1.5	1.3 units on a scale STANDARD_DEVIATION 1.5
Rheumatoid Arthritis Impact of Disease (RAID)	3.6 units on a scale STANDARD_DEVIATION 2.4	3.7 units on a scale STANDARD_DEVIATION 2.3	3.7 units on a scale STANDARD_DEVIATION 2.4
Sex: Female, Male Female	38 Participants	45 Participants	83 Participants
Sex: Female, Male Male	22 Participants	17 Participants	39 Participants
Smoking ever	30 Participants	27 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 30	0 / 62
other Total, other adverse events	0 / 30	0 / 30	0 / 62
serious Total, serious adverse events	0 / 30	0 / 30	0 / 62

Outcome results

Primary

Arthritis Self-Efficacy Scale (ASES)

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.