NCT06066021Completed
Evaluation of a Health Education Program for Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 31 Jul 2024
Brief summary (registry, in English)
The goal of this, Retrospective and Prospective Low- Interventional study, is to implement health education interventions to promote self-care and reduce disease complications in DM Type 2 patients at higher risk of development/progression of Diabetic Retinopathy. \]. The main question it aims to answer are: * To evaluate the impact of a health education intervention on mental health, self-care behaviors, and disease knowledge in patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy. * To evaluate the impact of a health education intervention on the metabolic control of patients with Diabetes Mellitus Type 2 with high risk of development/progression of Diabetic Retinopathy. Patients will have to (V1 and V4): * answer three questionnaires, (Summary of Diabetes Self-Care Activities - SDSCA, QCD- Diabetes Knowledge Questionnaire and Depression Anxiety and Stress Scale" (DASS-21). * measurement of weight and height, to calculate BMI. * collection of glycated hemoglobin analysis (if they have been done in the last 3 months).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 12 Sept 2023
- Start date
- 13 Oct 2023
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Diseases
- Type 2 diabetes
- NCT number
- NCT06066021
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From 13 Oct 2023 to the primary completion date, 15 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other retinal vascular diseases than DR
Other
- Type 1 DM
- Moderately Severe NPDR;
- Presence of DME or PDR
Who the study is looking for
- Subjects with type 2 DM participating in STAR (CEC/008/16) and EYEMARKER (CEC/009/17)
- Higher risk patients through the RetinaRisk ® app ≥ 3%
- Age ≥50 years
- Body mass index (IMC) ≥ 25;
- Glycated hemoglobin (HbA1C): ≥6.5%; (7)
- Arterial hypertension (HTA): ≥ 139-89 (8)
- Presence of mild to moderate NPDR with presence of visible retina lesions (microaneurysms, hemorrhages, hard exudates and soft exudates)
- Subjects capable of understanding the information about the study and giving their informed consent to enter the study.
- Subjects willing and able to comply with the study.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIBILI-CEC (AIBILI- Clinical Trials Centre) Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.