Retinopathy, DiabeticEDUCA-DMNCT06066021
Evaluation of a Health Education Program for Type 2 Diabetes Patients
A study testing health educational sessions in diabetic patients type 2. in people with Retinopathy, Diabetic, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial 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. ]. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Retinopathy, Diabetic
- What is being tested?
- health educational sessions in diabetic patients type 2.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Oct 2023to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- Type 1 DM
- Moderately Severe NPDR;
- Presence of DME or PDR
- Other retinal vascular diseases than DR
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
Read the detailed description
Diabetic retinopathy (DR) is the most frequent complication of Diabetes mellitus and the main cause of legal blindness in working populations in industrialized countries.
A diagnosis of diabetes has important implications for individuals, not only for their health, but also because of the stigma that a diagnosis can bring, i.e., it can affect employment, quality of life, mental health, social opportunities, and other cultural aspects. These changes in the lives of diabetics can lead to stress. It is known that diabetes has a social and family connotation that leads to depression and anxiety appearing in parallel, which can influence the self-management that people must do in their daily lives. It is necessary to incorporate and integrate mental health care into all diabetic care.
Individuals with diabetes have difficulties: diagnosis, adherence to treatment, fear of complications and hypoglycemia, which can result in suffering, thus making self-management difficult.
In diabetic patients, the prevalence of symptoms of depression and anxiety is about two to four times higher than in the general population. Metabolic dysregulation influences brain function and disturbances in glucose regulation may be associated with depression. These emotions that arise can be disabling and very strong, leading the individual to often acquire behaviors that do not help in fighting the disease. There may be changes in eating behavior, or alcoholic beverages that are not favorable to glycemic control, that is, glycaemia rises proportionally to the most negative events in life, thus, stress leads to an increase in corticosteroids and consequently increases glycaemia. It is known that physical activity can reduce disease rates, namely diabetes, hypertension, obesity, among others. There are studies that show that physical activity is beneficial, whatever its intensity. It reduces the admission of chronically ill patients to hospitals, reduces pain and increases mental health and quality of life. With the development of physical activity programs applied to chronically ill patients, they are beneficial to promote the management of their disease, physical and mental health, and reduce the appearance of other comorbidities. In Diabetes Mellitus, the causes are complex, and its complications can be prevented with a healthy diet, normal blood glucose, adequate weight, and physical activity. For health professionals, who deal with these chronically ill patients, they have a huge challenge, since these people present risk behaviors (unhealthy eating and/or sedentary lifestyle). To assess the disease, there is glycosylated hemoglobin (HbA1c), which reflects the average blood glucose. It is used as a risk parameter and considered the gold standard for assessing glycemic control. The American Diabetes Association (ADA) sets HbA1c < 7% as the threshold of good control for most people with diabetes. To improve glycemic control, nutritional monitoring is important. Nutrition education is considered a preventive and treatment strategy to provide diabetic people with the necessary tools to face the change in lifestyle and achieve self-management of the disease. For this, it is necessary to increase knowledge, acquisition of skills, as well as promote the modification of attitudes and behaviors. It is important to increase people's active participation in the control and treatment of their disease.
Diabetics should participate in self-care education actions with the body, to improve the knowledge, skills, and abilities necessary for the self-care of this pathology.
Based on the evidence collected at the EYEMARKER (NCT02500862), CEC/009/17 study "Characterization of potential biomarkers of Eye Disease and Vision Loss", (ongoing at AIBILI), and STAR screening program "Development of a Model for Advanced Screening for Timely Treatment of Age-Related Eye Diseases", CEC/008/16, it was observed from the beginning the existence of individuals with DM who need clarification and education about their condition and about the care and behaviors to adopt to have a better management of their disease and avoid possible complications. With this study, it is intended to identify, in EYEMARKER patients who also participate in the STAR screening program, which individuals with Diabetes Mellitus are at greater risk of progression/development of Diabetic Retinopathy (DR), to better direct health education plans to reduce disease complications. The identification of patients at higher risk, who will be the target of health promotion actions, will be done through the "RetinaRisk" mobile phone application. After this analysis, 27 individuals who are at greater risk will be chosen. Self-care, knowledge about Diabetes Mellitus disease, emotional state, and metabolic control will be evaluated, before and after the health education sessions.
- Conditions
- Retinopathy, Diabetic
- Being tested
- health educational sessions in diabetic patients type 2.
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: health educational sessions in diabetic patients type 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- - It applied to me a few times
- - It has applied to me many times
- - It applied to me most of the time
Measured: 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)
Measured: 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
Measured: 3 months
Secondary outcomes (2)
Measure the change in the blood HbA1C level
Measure the change in the blood HbA1C level after the health education intervention training sessions.
The unit of measurement for HbA1c is in percentage (%).
Measured: 3 months
Measure the change in BMI
Measure the change in BMI after the health education intervention training sessions.
The unit of measurement for BMI is expressed in units of kg/m2 (weight in kilograms and height in meters).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start13 Oct 2023
- Primary completion15 Nov 2023
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Retinopathy, DiabeticStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066021
- Sponsor's protocol ID
- CEC/013/23
- Acronym
- EDUCA-DM
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25789112Ambury 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.
PubMed 32107219Kozlowska 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.
PubMed 28963429Alessi 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.
PubMed 32879637Cheval 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.
PubMed 34548372Funnell 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.
PubMed 19118294WHO. Use of glycated haemoglobin (HbA1c) in diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. Geneva; 2011; [cited 2022 Mar 20].Available from: http://www.who.int/iris/handle/10665/70523
Sociedade Portuguesa de Hipertensão. (2020). Sociedade Portuguesa de Hipertensão. Sociedade Portuguesa de Hipertensão. https://www.sphta.org.pt/pt/base8_detail/24/89
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
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.
PubMed 22762449Sousa, 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health Education Program for Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06066021
- Acronym / sponsor ID
- EDUCA-DM / CEC/013/23
- Conditions
- Retinopathy, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 4 Oct 2023 (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 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).
Detailed description
Diabetic retinopathy (DR) is the most frequent complication of Diabetes mellitus and the main cause of legal blindness in working populations in industrialized countries.
A diagnosis of diabetes has important implications for individuals, not only for their health, but also because of the stigma that a diagnosis can bring, i.e., it can affect employment, quality of life, mental health, social opportunities, and other cultural aspects. These changes in the lives of diabetics can lead to stress. It is known that diabetes has a social and family connotation that leads to depression and anxiety appearing in parallel, which can influence the self-management that people must do in their daily lives. It is necessary to incorporate and integrate mental health care into all diabetic care.
Individuals with diabetes have difficulties: diagnosis, adherence to treatment, fear of complications and hypoglycemia, which can result in suffering, thus making self-management difficult.
In diabetic patients, the prevalence of symptoms of depression and anxiety is about two to four times higher than in the general population. Metabolic dysregulation influences brain function and disturbances in glucose regulation may be associated with depression. These emotions that arise can be disabling and very strong, leading the individual to often acquire behaviors that do not help in fighting the disease. There may be changes in eating behavior, or alcoholic beverages that are not favorable to glycemic control, that is, glycaemia rises proportionally to the most negative events in life, thus, stress leads to an increase in corticosteroids and consequently increases glycaemia. It is known that physical activity can reduce disease rates, namely diabetes, hypertension, obesity, among others. There are studies that show that physical activity is beneficial, whatever its intensity. It reduces the admission of chronically ill patients to hospitals, reduces pain and increases mental health and quality of life. With the development of physical activity programs applied to chronically ill patients, they are beneficial to promote the management of their disease, physical and mental health, and reduce the appearance of other comorbidities. In Diabetes Mellitus, the causes are complex, and its complications can be prevented with a healthy diet, normal blood glucose, adequate weight, and physical activity. For health professionals, who deal with these chronically ill patients, they have a huge challenge, since these people present risk behaviors (unhealthy eating and/or sedentary lifestyle). To assess the disease, there is glycosylated hemoglobin (HbA1c), which reflects the average blood glucose. It is used as a risk parameter and considered the gold standard for assessing glycemic control. The American Diabetes Association (ADA) sets HbA1c < 7% as the threshold of good control for most people with diabetes. To improve glycemic control, nutritional monitoring is important. Nutrition education is considered a preventive and treatment strategy to provide diabetic people with the necessary tools to face the change in lifestyle and achieve self-management of the disease. For this, it is necessary to increase knowledge, acquisition of skills, as well as promote the modification of attitudes and behaviors. It is important to increase people's active participation in the control and treatment of their disease.
Diabetics should participate in self-care education actions with the body, to improve the knowledge, skills, and abilities necessary for the self-care of this pathology.
Based on the evidence collected at the EYEMARKER (NCT02500862), CEC/009/17 study "Characterization of potential biomarkers of Eye Disease and Vision Loss", (ongoing at AIBILI), and STAR screening program "Development of a Model for Advanced Screening for Timely Treatment of Age-Related Eye Diseases", CEC/008/16, it was observed from the beginning the existence of individuals with DM who need clarification and education about their condition and about the care and behaviors to adopt to have a better management of their disease and avoid possible complications. With this study, it is intended to identify, in EYEMARKER patients who also participate in the STAR screening program, which individuals with Diabetes Mellitus are at greater risk of progression/development of Diabetic Retinopathy (DR), to better direct health education plans to reduce disease complications. The identification of patients at higher risk, who will be the target of health promotion actions, will be done through the "RetinaRisk" mobile phone application. After this analysis, 27 individuals who are at greater risk will be chosen. Self-care, knowledge about Diabetes Mellitus disease, emotional state, and metabolic control will be evaluated, before and after the health education sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health education sessions for type 2 diabetic patients | Other | Other: health educational sessions in diabetic patients type 2.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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- Type 1 DM
- Moderately Severe NPDR;
- Presence of DME or PDR
- Other retinal vascular diseases than DR
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 |
|---|---|---|
| health educational sessions in diabetic patients type 2.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. | Other | Health education sessions for type 2 diabetic patients |
Primary outcome
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21)
Time frame: 3 months
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
Change in the Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: 3 months
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)
Change in the Diabetes Knowledge Questionnaire (DKQ - Portuguese version)
Time frame: 3 months
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
2 secondary outcomes
Measure the change in the blood HbA1C level
Time frame: 3 months
Measure the change in BMI
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 25789112Eisma 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.
- Background: PubMed 32107219Ambury 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.
- Background: PubMed 28963429Kozlowska 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.
- Background: PubMed 32879637Alessi 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.
- Background: PubMed 34548372Cheval 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.
- Background: PubMed 19118294Funnell 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.
- BackgroundWHO. Use of glycated haemoglobin (HbA1c) in diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. Geneva; 2011; [cited 2022 Mar 20].Available from: http://www.who.int/iris/handle/10665/70523
- BackgroundSociedade Portuguesa de Hipertensão. (2020). Sociedade Portuguesa de Hipertensão. Sociedade Portuguesa de Hipertensão. https://www.sphta.org.pt/pt/base8_detail/24/89
- BackgroundEbrahem, 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: PubMed 22762449Trief 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.
- BackgroundSousa, 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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health educational sessions in diabetic patients type 2. in people with Retinopathy, Diabetic, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066021, which also lists 11 linked publications.
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 31 Jul 2024.