A tailored, interactive health communication application for patients with type 2 Diabetes: study protocol of a randomised controlled trial

BACKGROUND: Type 2 diabetes is an increasingly common chronic condition whose prognosis can be improved by patient involvement and self-management. Patient involvement can be fostered by web-based Interactive Health Communication Applications (IHCAs) combining health information with decision support, social support and/or behaviour change support. They reach great numbers of patients at low cost and provide high-quality information and support at the time, place and learning speed patients prefer. Still, online tools often suffer from high attrition. Tailoring content and tone of IHCAs to the individual patient´s needs might improve their effectiveness. This study aims to test the effectiveness and usage of a tailored IHCA combining health information with decision support and behaviour change support for patients with type 2 diabetes.

METHODS/DESIGN: The effectiveness and usage of the tailored IHCA will be tested against a standard website with identical content in a single-blinded randomized trial with a parallel design. The content covers information on type 2 diabetes, its complications and sequelae, and its treatment options including health behaviour. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, attitudes towards self-care, and barriers to insulin treatment). In the control group the different sections are presented in a content tree, without any tailoring. Participants are blinded to group assignment. Eligibility criteria are age ≥ 18 years, self-reported type 2 diabetes, and Internet access. The study aims to include 414 participants in order to detect the expected small effect (Cohen's d=0.2), with measurements at baseline, directly after the first visit, and at 3-month follow-up. The primary hypothesis is that the tailored IHCA has larger effects on diabetes knowledge and patient empowerment (primary outcomes) than the standard website. Secondary outcomes are website usage as well as decisional conflict and preparation for decision making. All measurements are online self-report questionnaires.

DISCUSSION: IHCAs are a promising way to foster diabetes knowledge and self-management competencies. The present trial tries to increase the knowledge on how to develop more effective IHCAs for patients with type 2 diabetes.

TRIAL REGISTRATION: International Clinical Trials Registry DRKS00003322.