Type 2 DiabetesJACARDINCT06904690
JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes
A study testing Educational training in people with Type 2 Diabetes, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Educational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Nov 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low eHealth literacy (eHeals scale ≤ 29)
- No acute or untreated medical problems
- Mini Mental State Examination (MMSE) ≥ 24
- Geriatric Depression Scale (GDS) < 2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
AOU Ospedaliera Marche
Ancona, 60127
Roberta Papa
Massimiliano Petrelli, MD
- Recruiting
IRCCS INRCA Hospital
Ancona, 60127
Elena Tortato, MD, 0718003550, e.tortato@inrca.it
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Educational training
- Keywords
- Type 2 diabetes, eHealth literacy, elderly subjects, wellbeing, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| diabetic subjects | Experimental | Subjects with type 2 diabetes who have low eHealth literacy. Receives: Other: Educational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
eHealth literacy
Measured using the eHealth Literacy Scale (eHEALS). Scores range from 8 to 40, with higher scores indicating higher eHealth literacy.
Measured: Baseline and 10, 14 and 34 weeks later
Secondary outcomes (5)
Health literacy
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).
Measured: Baseline and 10, 14 and 34 weeks later
Health-related quality of life
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.
Measured: Baseline and 10, 14 and 34 weeks later
Psychological well-being
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.
Measured: Baseline and 10, 14 and 34 weeks later
Diabetes related emotional distress
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.
Measured: Baseline and 10, 14 and 34 weeks later
Health-related quality of life
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.
Measured: Baseline and 10, 14 and 34 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Nov 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Roberta Bevilacqua, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904690
- Sponsor's protocol ID
- INRCA_003_2025
- Acronym
- JACARDI
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JACARDI: A eHealth and Health Literacy Educational Training to Support Older Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT06904690
- Acronym / sponsor ID
- JACARDI / INRCA_003_2025
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, eHealth literacy, elderly subjects, wellbeing, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic subjects | Experimental | Other: Educational trainingSubjects with type 2 diabetes who have low eHealth literacy. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low eHealth literacy (eHeals scale ≤ 29)
- No acute or untreated medical problems
- Mini Mental State Examination (MMSE) ≥ 24
- Geriatric Depression Scale (GDS) < 2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational trainingThe 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. | Other | diabetic subjects |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberta Bevilacqua principal investigator
IRCCS INRCA, Ancona, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training in people with Type 2 Diabetes, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eHealth literacy (time frame: Baseline and 10, 14 and 34 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.