impact of a hybrid medical care model in the rheumatoid arthritis patient-reported-outcomes measures

Conditions: Rheumatoid Arthritis; Telehealth

Summary: the covid-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients. the primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the patient reported outcomes measures (proms), to the face-to-face medical care model, among rheumatoid arthritis (ra) outpatients. we also aim to investigate if adherence to ra-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model. in mexico, covid-19 pandemic still uncontrolled. our institution provides health care to 1500 ra patients/year and up to august 2020, it is estimated that 500 ra patients might be affected, which is our target audience. reinstalling institutional health care provision is challenging. this a non-inferiority, cross-over study, with 2 intervention arms. patients will be randomized to 1. six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model. the following proms will be assessed at specific time points: disease activity/disease severity (rapid-3), disability (haq-di), quality of life (whoqol-bref), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to ra-related treatment (the compliance-questionnaire).

this a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms: intervention 1: patients assigned to 6 months of usual medical care model, followed by 4 months control period, and finally 6 months of hybrid medical care model. intervention 2: patients assigned to 6 months of hybrid medical care model, followed by 4 months control period and finally 6 months of usual medical care model. specific objectives are as follows: primary objectives 1. to compare the mean disease activity of ra patients (as measured per rapid-3), after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2. 2. to compare the ra patient´s quality of life (as measured per whoqol-bref) and ra patient's disability (as measured per haq-di) after 6 months since study entry, between patients assigned to intervention 1 and patients assigned to intervention 2. secondary objectives: 1. at the end of the complete follow-up period, for each patient, to compare the cumulative ra disease activity during the 6 months period where patients received usual medical care model, with the cumulative disease activity during the 6 months period where patients received hybrid medical care model. 2. at the end of the complete follow-up period, for each patient, to compare patient´s satisfaction with usual medical care model and patient´s satisfaction to hybrid medical care model. 3. at the end of the complete follow-up period, for each patient, to compare patient´s adherence to the usual medical care model with patient´s adherence to hybrid medical care model.

Eligibility criteria:
inclusion criteria: * patients with ra diagnosis according to their primary rheumatologist * with at least six months of follow-up (up to march 2020) at the outpatient clinic * who agree to participate exclusion criteria: * patients lost to follow-up from the outpatient clinic before march 2020 * patients with no access to a mobile device during their study participation * patients with severe cognitive, visual and hearing impairment * patients on palliative care because of comorbid condition

Keywords: rheumatoid arthritis