Development, Validation, and Evaluation of Web-Based Iranian Diabetic Personal Health Record: Rationale for and Protocol of a Randomized Controlled Trial

Abstract

BackgroundDiabetes is one of the four main types of noncommunicable or chronic diseases. Iran is among the countries with the highest incidence of diabetic patients. A study demonstrated that the collection of diabetic data is neither organized nor standardized. There is currently no instance of electronic personal health records particularly used for diabetic patients in Iran, hence the need for one, which will be useful for self-care of diabetic patients.ObjectiveThe objective of the study is to examine the impact of a Web-based diabetic personal health record (DPHR) on the self-care status of diabetic patients as compared with the control group.MethodsThis study is a randomized control trial, which involves a systematic review of literature of the preferred data elements regarding a DPHR, and reevaluating the results with the opinions of local endocrinologists. Inclusion criteria were as follows: type 2 diabetic patients between 20-70 of age who live in the Mashhad City and having the disease for at least one year. The sample size is 72 people that were randomly assigned to the control and intervention groups. The participants in the intervention group were allowed access to the Web-based DPHR system, while those in the control group will continue to receive the usual care for 4 months. The study primary outcome measures include self-care status of participants and planned visit adherence.ResultsAt the moment, there is an ongoing recruitment of participants, and preliminary results will be published in early 2016.ConclusionsWe expect the final DPHR model, developed and tested during this study, to help diabetic patients to actively participate in their care management process, and also to empower the physician in providing more quality informed decisions regarding their patients.Trial Registrationirct.ir IRCT2013082914522N1; http://www.irct.ir/searchresult.php?id=14522&number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau).