NCT06904690

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 24, 2025

Last Update Submit

March 29, 2025

Conditions

Type 2 Diabetes

Keywords

Type 2 diabeteseHealth literacyelderly subjectswellbeingquality of life

Outcome Measures

Primary Outcomes (1)

  • eHealth literacy

    Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.

    Baseline and 10, 14 and 34 weeks later

Secondary Outcomes (5)

  • Health literacy

    Baseline and 10, 14 and 34 weeks later

  • Health-related quality of life

    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

  • Health-related quality of life

    Baseline and 10, 14 and 34 weeks later

Study Arms (1)

diabetic subjects

EXPERIMENTAL

Subjects with type 2 diabetes who have low eHealth literacy.

Other: Educational training

Interventions

Educational trainingOTHER

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-Evaluation and Sustainability of Improvement (Final Questionnaire). The training will be conducted over 10 weeks (one session every other week), with each session lasting an average of 90 minutes.

diabetic subjects

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AOU Ospedaliera Marche

Ancona, 60127, Italy

NOT YET RECRUITING

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Training Support

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Officials

  • Roberta Bevilacqua

    IRCCS INRCA, Ancona, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 1, 2025

Study Start

November 15, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)