JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes

Overview

The JACARDI trial is a multicenter study involving an educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes.

Detailed description

The JACARDI trial is a multicentric study organized as a blended didactic and interactive educational training, with the general objective to improve the eHealth of older adults in relation to the management of type 2 diabetes, thus contributing to independent living, and reduce risks of negative consequences for the health status and quality of life.

The trial will be preceded by a pre-study, needed to personalize and finalize the contents of the training, together with the beneficiaries of the study. In particular, during the pre-study, a population with similar characteristics of the target group will be involved in focus groups to refine the contents and practicalities of the training before the recruitment starts.

The primary end-point of the JACARDI trial is the improvement of the eHealth literacy after the conduction of the training, to be measured through the eHEALS scale, after 10 weeks of training. The training consisting of 5 modules and will be conducted over 10 weeks (one session every other week), with each session lasting an average of 90 minutes.

Interventions

• Other Educational training
  The educational training is divided into the following five modules: Module 1: Raising Awareness of eHealth and Health Literacy (Introduction to the aims and context of JACARDI and diabetes); Module 2: Acquiring New Knowledge (Health Literacy and Self-Management of Diabetes); Module 3: Acquiring New Knowledge (Technological and Non-Technological Strategies to Support the Self-Management of Diabetes); Module 4: Practicing New Skills (Usability with Practice Sessions); Module 5: Self-Evaluati

Primary outcome measures

• eHealth literacy [Time frame: Baseline and 10, 14 and 34 weeks later]

Secondary outcome measures (5)

• Health literacy [Time frame: Baseline and 10, 14 and 34 weeks later]
• Health-related quality of life [Time frame: Baseline and 10, 14 and 34 weeks later]
• Psychological well-being [Time frame: Baseline and 10, 14 and 34 weeks later]
• Diabetes related emotional distress [Time frame: Baseline and 10, 14 and 34 weeks later]
• Health-related quality of life [Time frame: Baseline and 10, 14 and 34 weeks later]

Eligibility criteria

Inclusion criteria

• Low eHealth literacy (eHeals scale ≤ 29)
• No acute or untreated medical problems
• Mini Mental State Examination (MMSE) ≥ 24
• Geriatric Depression Scale (GDS) < 2

Exclusion criteria

• A myocardial infarction or stroke within 6 months
• Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility
• Uncontrolled hypertension
• Advanced Parkinson's disease or other neuromuscular disorder
• Metastatic cancer or immunosuppressive therapy
• Significant visual or hearing impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 2 centers

• AOU Ospedaliera Marche — Ancona
• IRCCS INRCA Hospital — Ancona

Identifiers

NCT: NCT06904690 · INRCA_003_2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗