Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 25, 2020
Open Peer Review Period: Sep 22, 2020 - Nov 16, 2020
Date Accepted: Mar 17, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
iMedA: improving medication adherence through adaptive digital interventions in patients with hypertension: Protocol for an Interrupted time-series study
ABSTRACT
Background:
There is a strong need to improve medication adherence (MA) for hypertensive patients in order to reduce long-term hospitalization costs. We believe this can be achieved through an AI agent that helps the patient in understanding key individual adherence risk factors and designing an appropriate intervention plan. The incidence of hypertension in Sweden is estimated at approximately 27%. Among American adults diagnosed with hypertension only 54% had their condition under control; another 32% had prehypertension-level blood pressure. The direct and indirect healthcare costs due to uncontrolled hypertension in the US alone are estimated at 49 billion dollars each year. It is a major risk factor for coronary heart disease and stroke as well as heart failure. MA is a key factor for good clinical outcomes in hypertensive patients.
Objective:
The overall aim of this study is to design, develop, test, and evaluate an adaptive digital intervention called iMedA, delivered via a mobile app to improve MA and self-care management, and in longer-term blood pressure control, for persons with hypertension.
Methods:
The study design is considered to be an interrupted time series (ITS). We will collect data on a daily basis, 14 days before, during 6 months of delivering digital interventions through the mobile app, and after that. The effect will be analyzed using segmented regression analysis. The participants will be recruited in Region Halland, Sweden. The design of the digital interventions follows the Just-In-Time Adaptive Intervention (JITAI) framework. The primary (distal) outcome is MA, and the secondary outcome is blood pressure. The design of the digital intervention is developed based on a need assessment process including a systematic review, focus group interviews, and a pilot study, before going for the longitudinal ITS study.
Results:
The focus groups of persons with hypertension have been conducted to perform the need assessment. The design and development of digital interventions is under progress and is planned to be ready in September 2020. Then the 2-week pilot study for usability evaluation will get started, and then the ITS study will follow it, which we plan to start in October 2020.
Conclusions:
We hypothesize that iMedA will improve medication adherence and self-care management. This study could illustrate how self-care management tools can be an additional (digital) treatment support to a clinical one without increasing burden on healthcare staff. Clinical Trial: ClinicalTrials.gov NCT04413500; https://clinicaltrials.gov/ct2/show/NCT04413500medication adherence; hypertension; digital intervention; mHealth; Artificial Intelligence
Citation
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