Educational Intervention for Self-Care in Patients With Coronary Heart Disease and Type 2 Diabetes

NCT07852715 | Completed

• 1 other identifier: 11.08.2021/52-5
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Heart Disease (CHD); Diabetes Mellitus, Type 2

Keywords

self-care; patient education; nursing intervention; glycemic control; HbA1c

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (3)

• Glycated Hemoglobin (HbA1c)

  Baseline, 3 months, and 6 months

• Low-Density Lipoprotein Cholesterol (LDL-C)

  Baseline, 3 months, and 6 months

• Body Mass Index (BMI)

  Baseline, 3 months, and 6 months

Study Arms (2)

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.

Behavioral: Experimental

Interventions

Experimental BEHAVIORAL

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.

Educational Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Süleyman Demirel University Research and Application Hospital

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: August 1, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning after publication of the study results and for as long as permitted by institutional data-retention requirements
• Access Criteria: De-identified individual participant data may be provided to researchers who submit a reasonable and scientifically appropriate request to the corresponding author. Requests will be evaluated in accordance with ethical and institutional requirements. A data-use agreement may be required before data are shared.

Locations

TU (1)