Coronary Heart Disease (CHD)NCT07852715
Educational Intervention for Self-Care in Patients With Coronary Heart Disease and Type 2 Diabetes
A study testing Experimental in people with Coronary Heart Disease (CHD) and Diabetes Mellitus, Type 2, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn whether a structured educational intervention could improve self-care and selected clinical outcomes in adults with both coronary heart disease and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD), Diabetes Mellitus, Type 2
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 23 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older Diagnosis of both coronary heart disease and type 2 diabetes mellitus for at least 6 months Ability to read and write Ability to communicate in Turkish Ability to communicate by telephone during follow-up No previous self-care education specifically addressing both diabetes and coronary heart disease Willingness to provide written informed consent
Who cannot join
- Previous receipt of self-care education specifically addressing both diabetes and coronary heart disease Inability to communicate in Turkish or by telephone during follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süleyman Demirel University Research and Application Hospital
Isparta, 32200
About this study
Official title: The Effect of an Educational Intervention on Glycemic Control and Self-Care Behaviors in Patients With Coronary Heart Disease and Type 2 Diabetes
The goal of this clinical trial was to learn whether a structured educational intervention could improve self-care and selected clinical outcomes in adults with both coronary heart disease and type 2 diabetes.
The main questions were:
Read more
Does the educational intervention improve self-care related to coronary heart disease and diabetes? Does the educational intervention improve blood sugar control, body mass index, and low-density lipoprotein cholesterol?
Participants were randomly assigned to an intervention group or a control group. Participants in the intervention group received one individual face-to-face education session about self-care for coronary heart disease and diabetes, supported by an educational booklet. They also received brief telephone follow-up contacts at weeks 1 and 4 to reinforce the self-care information, discuss problems they experienced, and answer their questions. Participants in the control group continued to receive usual clinical care.
Researchers assessed self-care, glycated hemoglobin (HbA1c), body mass index, and low-density lipoprotein cholesterol at the start of the study and again at 3 and 6 months.
- Being tested
- Experimental
- Keywords
- self-care, patient education, nursing intervention, glycemic control, HbA1c
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Participants received one-to-one face-to-face self-care education addressing coronary heart disease and type 2 diabetes, supported by an educational booklet. The educational content was delivered in approximately 30 minutes, followed by 10-20 minutes of discussion about participants' questions, concerns, and self-care difficulties. The total session lasted 40-50 minutes. Brief telephone follow-up contacts were conducted at weeks 1 and 4 to reinforce the self-care information provided during the education, discuss problems experienced, and answer participants' questions. These telephone contacts generally lasted 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control Group | No intervention | Participants continued to receive usual clinical care. Hospitalized participants received routine discharge information regarding medications and scheduled follow-up visits, while outpatients continued their routine physician follow-up. No study-specific education or telephone follow-up intervention was provided by the research team. |
| Educational Intervention Group | Experimental | Participants received one-to-one face-to-face self-care education addressing coronary heart disease and type 2 diabetes, supported by an educational booklet. The session lasted approximately 40-50 minutes. Brief telephone follow-up contacts were conducted at weeks 1 and 4 to reinforce self-care information, discuss problems experienced, and answer participants' questions. Usual clinical care continued throughout the study. Receives: Behavioral: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Heart Disease Self-Care Maintenance
Self-care maintenance was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care maintenance subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating better self-care maintenance
Measured: Baseline, 3 months, and 6 months
Coronary Heart Disease Self-Care Management
Self-care management was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care management subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating better self-care management.
Measured: Baseline, 3 months, and 6 months
Coronary Heart Disease Self-Care Confidence
Self-care confidence was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care confidence subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating greater self-care confidence.
Measured: Baseline, 3 months, and 6 months
Diabetes Self-Care
Diabetes self-care was assessed using the Diabetes Self-Care Scale (DSCS). The 35-item scale is scored from 35 to 140, with higher scores indicating better diabetes self-care behaviors. A score of 92 or higher represents the minimum acceptable level of self-care.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (3)
Glycated Hemoglobin (HbA1c)
HbA1c was used as an indicator of glycemic control. Values were obtained from laboratory tests performed as part of routine clinical care at the study hospital. Baseline values were taken from the most recent test within the previous month, and follow-up values were obtained at 3 and 6 months.
Measured: Baseline, 3 months, and 6 months
Low-Density Lipoprotein Cholesterol (LDL-C)
LDL-C was used as an indicator of lipid control. Values were obtained from laboratory tests performed as part of routine clinical care at the study hospital. Baseline values were taken from the most recent test within the previous month, and follow-up values were obtained at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Body mass index was calculated at baseline, 3 months, and 6 months. Baseline BMI was calculated using self-reported height and weight. At 3 and 6 months, participants reported their weight measured at home or at a pharmacy, preferably using the same scale, and BMI was calculated using the baseline height.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Aug 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to an educational intervention group or a usual-care control group and were followed in parallel for 6 months
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Bayrak, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852715
- Sponsor's protocol ID
- 11.08.2021/52-5
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request to the corresponding author, subject to ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Educational Intervention on Glycemic Control and Self-Care Behaviors in Patients With Coronary Heart Disease and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07852715
- Acronym / sponsor ID
- 11.08.2021/52-5
- Keywords
- self-care, patient education, nursing intervention, glycemic control, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 1 Oct 2026 (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 clinical trial was to learn whether a structured educational intervention could improve self-care and selected clinical outcomes in adults with both coronary heart disease and type 2 diabetes.
The main questions were:
Does the educational intervention improve self-care related to coronary heart disease and diabetes? Does the educational intervention improve blood sugar control, body mass index, and low-density lipoprotein cholesterol?
Participants were randomly assigned to an intervention group or a control group. Participants in the intervention group received one individual face-to-face education session about self-care for coronary heart disease and diabetes, supported by an educational booklet. They also received brief telephone follow-up contacts at weeks 1 and 4 to reinforce the self-care information, discuss problems they experienced, and answer their questions. Participants in the control group continued to receive usual clinical care.
Researchers assessed self-care, glycated hemoglobin (HbA1c), body mass index, and low-density lipoprotein cholesterol at the start of the study and again at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to an educational intervention group or a usual-care control group and were followed in parallel for 6 months
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control Group | No intervention | –Participants continued to receive usual clinical care. Hospitalized participants received routine discharge information regarding medications and scheduled follow-up visits, while outpatients continued their routine physician follow-up. No study-specific education or telephone follow-up intervention was provided by the research team. |
| Educational Intervention Group | Experimental | Behavioral: ExperimentalParticipants received one-to-one face-to-face self-care education addressing coronary heart disease and type 2 diabetes, supported by an educational booklet. The session lasted approximately 40-50 minutes. Brief telephone follow-up contacts were conducted at weeks 1 and 4 to reinforce self-care information, discuss problems experienced, and answer participants' questions. Usual clinical care continued throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Diagnosis of both coronary heart disease and type 2 diabetes mellitus for at least 6 months Ability to read and write Ability to communicate in Turkish Ability to communicate by telephone during follow-up No previous self-care education specifically addressing both diabetes and coronary heart disease Willingness to provide written informed consent
Key exclusion criteria (1 listed)
- Previous receipt of self-care education specifically addressing both diabetes and coronary heart disease Inability to communicate in Turkish or by telephone during follow-up
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 |
|---|---|---|
| ExperimentalParticipants received one-to-one face-to-face self-care education addressing coronary heart disease and type 2 diabetes, supported by an educational booklet. The educational content was delivered in approximately 30 minutes, followed by 10-20 minutes of discussion about participants' questions, concerns, and self-care difficulties. The total session lasted 40-50 minutes. Brief telephone follow-up contacts were conducted at weeks 1 and 4 to reinforce the self-care information provided during the education, discuss problems experienced, and answer participants' questions. These telephone contacts generally lasted 5-10 minutes. | Behavioural | Educational Intervention Group |
Primary outcome
Coronary Heart Disease Self-Care Maintenance
Time frame: Baseline, 3 months, and 6 months
Self-care maintenance was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care maintenance subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating better self-care maintenance
Coronary Heart Disease Self-Care Management
Time frame: Baseline, 3 months, and 6 months
Self-care management was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care management subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating better self-care management.
Coronary Heart Disease Self-Care Confidence
Time frame: Baseline, 3 months, and 6 months
Self-care confidence was assessed using the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). The self-care confidence subscale is scored separately and standardized to a 0-100 scale, with higher scores indicating greater self-care confidence.
Diabetes Self-Care
Time frame: Baseline, 3 months, and 6 months
Diabetes self-care was assessed using the Diabetes Self-Care Scale (DSCS). The 35-item scale is scored from 35 to 140, with higher scores indicating better diabetes self-care behaviors. A score of 92 or higher represents the minimum acceptable level of self-care.
3 secondary outcomes
Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 3 months, and 6 months
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Time frame: Baseline, 3 months, and 6 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 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request to the corresponding author, subject to ethical and institutional requirements.
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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 Experimental in people with Coronary Heart Disease (CHD) and Diabetes Mellitus, Type 2, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 1 Oct 2026. 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 Turkey (Türkiye). 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?
Coronary Heart Disease Self-Care Maintenance (time frame: Baseline, 3 months, and 6 months). The study lists 4 primary outcomes in all. 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 Oct 2026.