Clinical trial NCT06904690: JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes
Official title: JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
eHealth literacy
elderly subjects
wellbeing
quality of life
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2025-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: eHealth literacy
timeFrame: Baseline and 10, 14 and 34 weeks later
Secondary outcomes:
measure: Health literacy
timeFrame: Baseline and 10, 14 and 34 weeks later
measure: Health-related quality of life
timeFrame: Baseline and 10, 14 and 34 weeks later
measure: Psychological well-being
timeFrame: Baseline and 10, 14 and 34 weeks later
measure: Diabetes related emotional distress
timeFrame: Baseline and 10, 14 and 34 weeks later
measure: Health-related quality of life
timeFrame: Baseline and 10, 14 and 34 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Ospedaliera Marche
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Roberta Bevilacqua
role: PRINCIPAL_INVESTIGATOR
References: