Evaluation of a Health Education Program for Type 2 Diabetes Patients

NCT06066021 | Completed

• 1 other identifier: CEC/013/23
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Retinopathy, Diabetic

Outcome Measures

Primary Outcomes (3)

• Change in Depression, Anxiety, and Stress Scale-21 (DASS-21)

  total and subscales scores (depression; anxiety; stress) three months after the health education intervention training sessions. The scale score,(lower scores mean a better result), (the minimum and maximum values): 0 - Nothing applied to me 1. \- It applied to me a few times 2. \- It has applied to me many times 3. \- It applied to me most of the time

  3 months

• Change in the Summary of Diabetes Self-Care Activities (SDSCA)

  total and subscales scores (general diet; specific diet; exercise; blood-glucose testing; foot-care; smoking) three months after the health education intervention training sessions. The scale used is number of days (from 0 to 7)

  3 months

• Change in the Diabetes Knowledge Questionnaire (DKQ - Portuguese version)

  Subscales scores (treatment, control and complications; causes; duration) three months after the health education intervention training sessions. This consists of 20 items distributed by three dimensions (Treatment, control and complications, Causes and Duration).The minimum and maximum values is 0-100, the 0 is minimum and 100 is maximum

  3 months

Secondary Outcomes (2)

• Measure the change in the blood HbA1C level

  3 months

• Measure the change in BMI

  3 months

Study Arms (1)

Health education sessions for type 2 diabetic patients

OTHER

Patients will be pre-selected according to their risk of developing DR. It will be done through the Retina Risk® application. Will be invited to participate and followed. Retrospective and prospective data will be collected on medical and ophthalmological history (HbA1c value, if performed. 3 questionnaires will be carried out: DM disease, self-care, and emotional state, before and after awareness intervention about self-care through educational sessions in areas of greatest need (physical activity, nutrition, mental health, and self-care). The impact of the previously described sessions on the patients' health status will be assessed using 2 methods: By telephone and by physical examination. Repetition of the 3 questionnaires applied in V1. The Interventions will be made, through information sessions on the topics: mental health, nutrition, physical exercise, and care that diabetics must take to take care of their body.

Other: health educational sessions in diabetic patients type 2.

Interventions

health educational sessions in diabetic patients type 2. OTHER

Professionals from different areas will be invited to carry out the sessions at Visit 2, namely on: mental health, physical activity, nutrition and self-care.

Health education sessions for type 2 diabetic patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Type 1 DM
• Moderately Severe NPDR;
• Presence of DME or PDR
• Other retinal vascular diseases than DR

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (1)

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, 3000-548, Portugal

Location

Related Publications (11)

• Eisma JH, Dulle JE, Fort PE. Current knowledge on diabetic retinopathy from human donor tissues. World J Diabetes. 2015 Mar 15;6(2):312-20. doi: 10.4239/wjd.v6.i2.312.

  PMID: 25789112 BACKGROUND

• Ambury T. Mental health in diabetes: can't afford to address the service gaps or can't afford not to? Br J Gen Pract. 2020 Feb 27;70(692):108-109. doi: 10.3399/bjgp20X708365. Print 2020 Mar. No abstract available.

  PMID: 32107219 BACKGROUND

• Kozlowska O, Solomons L, Cuzner D, Ahmed S, McManners J, Tan GD, Lumb A, Rea R. Diabetes care: closing the gap between mental and physical health in primary care. Br J Gen Pract. 2017 Oct;67(663):471-472. doi: 10.3399/bjgp17X692993. No abstract available.

  PMID: 28963429 BACKGROUND

• Alessi J, de Oliveira GB, Franco DW, Brino do Amaral B, Becker AS, Knijnik CP, Kobe GL, de Carvalho TR, Telo GH, Schaan BD, Telo GH. Mental health in the era of COVID-19: prevalence of psychiatric disorders in a cohort of patients with type 1 and type 2 diabetes during the social distancing. Diabetol Metab Syndr. 2020 Aug 31;12:76. doi: 10.1186/s13098-020-00584-6. eCollection 2020.

  PMID: 32879637 BACKGROUND

• Cheval B, Finckh A, Maltagliati S, Fessler L, Cullati S, Sander D, Friese M, Wiers RW, Boisgontier MP, Courvoisier DS, Luthy C. Cognitive-bias modification intervention to improve physical activity in patients following a rehabilitation programme: protocol for the randomised controlled IMPACT trial. BMJ Open. 2021 Sep 21;11(9):e053845. doi: 10.1136/bmjopen-2021-053845.

  PMID: 34548372 BACKGROUND

• Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S87-94. doi: 10.2337/dc09-S087. No abstract available.

  PMID: 19118294 BACKGROUND

• Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK304267/

  PMID: 26158184 BACKGROUND

• Sociedade Portuguesa de Hipertensão. (2020). Sociedade Portuguesa de Hipertensão. Sociedade Portuguesa de Hipertensão. https://www.sphta.org.pt/pt/base8_detail/24/89

  BACKGROUND

• Ebrahem, S. M., & Masry, S. E. (2017). Effect of relaxation therapy on depression, anxiety, stress and quality of life among diabetic patients. Clinical Nursing Studies, 5(1), 35. https://doi.org/10.5430/cns.v5n1p35

  BACKGROUND

• Trief PM, Izquierdo R, Eimicke JP, Teresi JA, Goland R, Palmas W, Shea S, Weinstock RS. Adherence to diabetes self care for white, African-American and Hispanic American telemedicine participants: 5 year results from the IDEATel project. Ethn Health. 2013;18(1):83-96. doi: 10.1080/13557858.2012.700915. Epub 2012 Jul 5.

  PMID: 22762449 BACKGROUND

• Sousa, M. R., Pereira, F., Martins, T., Rua, I., Ribeiro, I., Cerdeira, C., Lopes, L., Sèvegrand, C., & Santos, C. (2019). Impact of an educational programme in Portuguese people with diabetes. Action Research, 17(2), 258-276. https://doi.org/10.1177/1476750317736369

  BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 4, 2023
• Study Start: October 13, 2023
• Primary Completion: November 15, 2023
• Study Completion: March 29, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

PT (1)