IMPLEMENTATION OF THE NOVEL HYPERTENSION-SPECIFIC PATIENT-REPORTED OUTCOME MEASURE IN M-HEALTH. A SINGLE-CENTRE EXPERIENCE

Abstract

Objective: Telehealth techniques are hugely involved in management of hypertension (HTN). Despite much evidence of clinical efficacy, the quality of life (QoL) is still poorly addressed in m-Health studies. Furthermore, generic tools are often used for QoL assessment. The aim was to assess QoL of blood pressure telemonitoring (BPTM) with the brand new HTN-specific patient-reported outcome measure called HYpertension imPact questionnairE (HYPE). Design and method: Conceptual model of HYPE was designed and the item pool was created by an expert panel consisting of 4 cardiologists, 2 psychologists. Validation survey was conducted in a 400-cohort of ambulatory patients with HTN Grades 1–3. Exploratory and confirmatory factor analyses (EFA and CFA respectively) were undertaken to confirm validity. Reliability was confirmed with Cronbach's alpha. Free and secure m-Health app was developed for BPTM. 100 patients were enrolled and allocated to BPTM (mean age 48 y.o.) and control (mean age 49 y.o.) in 1:1 ratio. The 6-month program was developed with baseline and end of study clinic visits and HYPE polling. Results: There were 5 factors (“symptoms”, “emotions”, “social issues”, “treatment efficacy” and “treatment adherence”) retained with respect to Cattel scree test. Of 80 initial questions only 35 were eligible due to EFA (factor loadings >0.5). CFA indicated SRMR was 0.08, RMSEA was 0.07 (90% CI [0.07–0.08]) and CFI was 0.08. Cronbach's alpha was more 0.80 for each of the factors and 0.89 for the whole scale confirming its reliability. Six-month results reaffirmed the clinical efficacy of BPTM (141,2 ± 10,2 vs 149,5 ± 8,4 mm Hg, p < 0.003). The vast majority of patients in BPTM achieved target office BP instead of control group (50% vs 15%). HYPE score was markedly higher in BPTM group than in controls (+22,4 [+16%] vs +5,6 [4%], p < 0.0001) at the end of the study. Qualitative substudy showed 70% positive patient experience with using BPTM. Conclusions: Novel patient-reported outcome measure is a solid tool for assessing different patterns of QoL in patients with HTN. BPTM seems to be effective especially in a patient-centered manner and paves the way for future telehealth studies focusing on quality of life in hypertensive subjects.