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

March 29, 2025 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60127
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
      • Ancona, Italy, 60127
        • Not yet recruiting
        • AOU Ospedaliera Marche
        • Contact:
          • Roberta Papa
        • Principal Investigator:
          • Massimiliano Petrelli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diabetic subjects
Subjects with type 2 diabetes who have low eHealth literacy.
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-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 10, 14 and 34 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured using the 16 items European Health Literacy Survey Questionnaire (HLS-EU-Q16). Each of the 16 items is answered by choosing one response from those available: 'very difficult', 'fairly difficult', 'fairly easy' and 'very easy. The four response categories are binarized (1 = "very easy / "fairly easy"; 0 = "very difficult" / "fairly difficult") and added together to form a total score: "adequate" (13-16 points), "problematic" (9-12 points) and "inadequate" (1-8 points).
Baseline and 10, 14 and 34 weeks later
Health-related quality of life
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured using the 5-level EQ-5D version (EQ-5D-5L) from the EuroQol Group. It includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Participants rate each of these items from 1 of the 5 levels: no problems, slight problems, moderate problems, severe problems, or unable to/extreme. A composite health state is then defined by combining the levels for each dimension into a 5-digit number.
Baseline and 10, 14 and 34 weeks later
Psychological well-being
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured by the Psychological Wellbeing Scale (PWB). A self-administered questionnaire consisting of 18 items that investigates the degree of psychological well-being by exploring six dimensions: self-acceptance, positive relationships with others, autonomy, environmental control, personal growth, and purpose of life. The questionnaire consists of 18 items on a 4-step Likert scale. The higher numbers indicate greater agreement with positive statements or disagreement with negative statements. Scores are calculated for each of the six dimensions by summing or averaging the responses to the items within that dimension.
Baseline and 10, 14 and 34 weeks later
Diabetes related emotional distress
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured by the Problem Areas in Diabetes Questionnaire (PAID). The PAID is a self-report questionnaire that contains 20 items describing negative emotions related to diabetes (e.g. fear, anger, frustration) commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 ("no problem") to 4 ("a serious problem").Scores range from 0 - 100, higer scores indicate worse outcome.
Baseline and 10, 14 and 34 weeks later
Health-related quality of life
Time Frame: Baseline and 10, 14 and 34 weeks later
Measured using the EQ visual analogue scale (EQ VAS) of the 5-level EQ-5D version (EQ-5D-5L) from the EuroQol Group. It measures self-rated health status utilizing a vertically oriented visual analogue scale where 100 represents the "best imaginable health state" and 0 represents the "worst imaginable health state." Respondents are asked to rate their current health by placing a mark along this continuum. The VAS provides a quantitative measure of the patient's perceived health state.
Baseline and 10, 14 and 34 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Collaborators

European Union

Investigators

  • Principal Investigator: Roberta Bevilacqua, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_003_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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