JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- eHealth literacy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
diabetic subjects
Subjects with type 2 diabetes who have low eHealth literacy.
Intervention: Educational training (Other)
Outcomes
Primary Outcomes
eHealth literacy
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.
Secondary Outcomes
- Health-related quality of life(Baseline and 10, 14 and 34 weeks later)
- Health literacy(Baseline and 10, 14 and 34 weeks later)
- Psychological well-being(Baseline and 10, 14 and 34 weeks later)
- Diabetes related emotional distress(Baseline and 10, 14 and 34 weeks later)