Patients’ satisfaction with a digital solution aiming for the monitoring and support of patients with immune-mediated rheumatologic diseases
| ISRCTN | ISRCTN11896540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11896540 |
| Secondary identifying numbers | HULP-PI-4519 |
- Submission date
- 15/06/2021
- Registration date
- 21/08/2021
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Supporting rheumatology patients undergoing immunological treatments is of great relevance. Mobile health technologies (mHealth) have the potential to bring actionable insights to clinicians following up on those patients whose health status often changes in between clinical visits. These patients are also in need of personalized education to better cope with the disease and improve both their physical and mental health. The aim of this study is to explore the feasibility of using a mobile health solution to support the personalized care of patients with a rheumatologic disease that requires immunological treatment.
Who can participate?
Patients aged over 18 years with immune-mediated inflammatory diseases, such as spondyloarthritis and rheumatoid arthritis, who are treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs) or specific targeted synthetic DMARDs (tsDMARDs)
What does the study involve?
Participants will be informed about the study and after checking eligibility criteria and signing informed consent they will be able to participate. They will receive a mobile application to access health education and behavioral change support, including access to questionnaires (psychometrics) that will support clinicians to provide them with more personalized care.
What are the possible benefits and risks of participating?
The main benefit is that participants will have access to personalized educational and behavioral support. In addition, their health status will be better monitored by their clinicians which eventually can lead to the improvement of the provision of care. The educational and behavioral content of the mobile solution focuses on the low-risk type of advice (e.g. stress management) and is not intended to substitute for advice from clinicians. Only clinicians involved in the provision of care will be able to identify the patients, thus minimizing any privacy risks.
Where is the study run from?
La Paz and Infanta Leonor University Hospitals (Spain)
When is the study starting and how long is it expected to run for?
March 2020 to June 2022
Who is funding the study?
Abbvie via an independent grant awarded to the Sociedad Española of Rheumatology (Spain)
Who is the main contact?
Chamaida Plasencia-Rodriguez
chamiplaro@gmail.com
Contact information
Scientific
Servicio de Reumatología
Hospital Universitario La Paz
Paseo de la Castellana, 261
Madrid
28046
Spain
 ORCID ID |
0000-0003-3503-9047 |
|---|---|
| Phone | +34 (0)607914606 |
| chamaida.plasencia@ser.es |
Study information
| Study design | Prospective observational multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility study of digital solutions to support and follow-up of patients with immune-mediated rheumatological diseases |
| Study acronym | DigiReuma |
| Study hypothesis | The purpose of this observational study is to measure the impact of the use of a digital solution on the quality of care perceived by patients. |
| Ethics approval(s) | Approved 27/01/2021, Comité de Ética de la Investigación del Hospital Universitario La Paz (Paseo de La Castellana 261, Hospital General, 8ª planta, Madrid, Spain; +34 (0)91 727 74 13; ceic.hulp@salud.madrid.org), ref: HULP-PI-4519 |
| Condition | Rheumatoid arthritis, axial spondyloarthritis |
| Intervention | Participants will be informed about the study and after checking eligibility criteria and signing informed consent they will be able to participate. They will receive a mobile application to access health education and behavioral change support, including access to questionnaires (psychometrics) to support clinicians in providing them with more personalized care. Total duration of observation: 6 months Total duration of follow-up: 6 months |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Impact of the mobile solution on patients’ satisfaction, measured using an ad-hoc questionnaire at 6 months 2. Engagement at an aggregated level measured continuously via users’ login frequency from recruitment until drop-out or the end of the follow-up |
| Secondary outcome measures | 1. Quality of life measured by Health Assessment Questionnaire (HAQ) at baseline, 1, 2, 3, 4, 5 and 6 months 2. Disease activity measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline, 1, 2, 3, 4, 5 and 6 months |
| Overall study start date | 02/03/2020 |
| Overall study end date | 20/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 56 |
| Participant inclusion criteria | 1. Over 18 years of age 2. Have a smartphone or tablet-type cell phone 3. Accepting participation in the study and signing the informed consent form 4. Patients under follow-up for at least 1 year in the Complex Therapies Unit of the Rheumatology service with a diagnosis of rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis |
| Participant exclusion criteria | 1. Not owning a mobile device compatible with the mHealth solution 2. Not being able to participate in the program without assistance |
| Recruitment start date | 30/06/2021 |
| Recruitment end date | 30/07/2021 |
Locations
Countries of recruitment
- Spain
Study participating centres
Hospital Universitario La Paz
Paseo de la Castellana, 261
Madrid
28046
Spain
Hospital Universitario Infanta Leonor
Avenida de la Gran Vía del Este, 80. Distrito Municipal de Villa de Vallecas
Madrid
28031
Spain
Sponsor information
Research organisation
C/ Marqués del Duero, 5, 1º
Madrid
28001
Spain
| Phone | +34 (0)915 767 799 |
|---|---|
| prensa.es@abbvie.com | |
| Website | https://www.ser.es/ |
"ROR" |
https://ror.org/01fm69p79 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AbbVie Inc., AbbVie U.S., AbbVie US, Allergan
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The researchers will disseminate their research through conventional academic outlets such as ACM, and IEEE sponsored conferences, and health informatics journals. |
| IPD sharing plan | In principle, the data will be held at a local database that will be used for the analysis, and it will be kept for safety reasons. The data underlying this article will be provided by the Digireuma Committee under licence / by permission. Data will be shared on request to the corresponding author Chamaida Plasencia-Rodríguez (chamaida.plasencia@ser.es) with the permission of the Digireuma Committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 20/07/2021 | No | No | ||
| Results article | 07/12/2022 | 06/09/2023 | Yes | No | |
| Results article | 25/09/2023 | 12/09/2024 | Yes | No |
Additional files
Editorial Notes
12/09/2024: Publication reference and total final enrolment added.
06/09/2023: Publication reference added.
20/07/2021: Trial's existence confirmed by the Comité de Ética de la Investigación del Hospital Universitario La Paz.
