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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Low eHealth literacy (eHeals scale ≤ 29)

No acute or untreated medical problems

Mini Mental State Examination (MMSE) ≥ 24

Geriatric Depression Scale (GDS) < 2

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Educational training

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: diabetic subjectsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 10, 14 and 34 weeks later

Secondary outcomes

1

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).

Time frame
Baseline and 10, 14 and 34 weeks later
2

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.

Time frame
Baseline and 10, 14 and 34 weeks later
3

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.

Time frame
Baseline and 10, 14 and 34 weeks later
4

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.

Time frame
Baseline and 10, 14 and 34 weeks later

Other outcomes

Sponsors and contacts

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