Patients’ satisfaction with a digital solution aiming for the monitoring and support of patients with immune-mediated rheumatologic 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

Study website

Type

Scientific

Contact name

Mrs Chamaida Plasencia Rodríguez

ORCID ID

http://orcid.org/0000-0003-3503-9047

Contact details

Servicio de Reumatología
Hospital Universitario La Paz
Paseo de la Castellana
261
Madrid
28046
Spain
+34 (0)607914606
chamaida.plasencia@ser.es

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

HULP-PI-4519

Scientific title

Feasibility study of digital solutions to support and follow-up of patients with immune-mediated rheumatological diseases

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

Study design

Prospective observational multicenter study

Primary study design

Observational

Secondary study design

Case series

Study setting(s)

Hospital

Study type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Reason abandoned (if study stopped)

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 type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

60

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

Countries of recruitment

Spain

Study participating centre

Hospital Universitario La Paz
Servicio de Reumatología
Hospital Universitario La Paz
Paseo de la Castellana, 261
Madrid
28046
Spain

Study participating centre

Hospital Universitario Infanta Leonor
Sección de Reumatología
Hospital Universitario Infanta Leonor
Avenida de la Gran Vía del Este, 80. Distrito Municipal de Villa de Vallecas
Madrid
28031
Spain

Organisation

Sociedad Española de Reumatología

Sponsor details

C/ Marqués del Duero
5
1º
Madrid
28001
Spain
+34 (0)915 767 799
prensa.es@abbvie.com

Sponsor type

Research organisation

Website

https://www.ser.es/

ROR

https://ror.org/01fm69p79

Funder type

Industry

Funder name

AbbVie

Alternative name(s)

AbbVie Inc., AbbVie U.S., AbbVie US, Allergan

Funding Body Type

government organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

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.

Intention to publish date

01/03/2022

Individual participant data (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.

IPD sharing plan summary

Not expected to be made available

Study outputs

• 40031_PROTOCOL.pdf