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The Effect of a Behavioral Counseling Program on Glycemic Control, Physical Function and Self-Management of Patients with Diabetes Susceptible to Peripheral Artery Disease

The Effect of a Behavioral Counseling Program on Glycemic Control, Physical Function and Self-Management of Patients with Diabetes Susceptible to Peripheral Artery Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150919024080N24
Enrollment
90
Registered
2025-03-30
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Diabetes. Condition 2: Peripheral Artery Disease (PAD). Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene

Interventions

Intervention 1: Intervention group: The intervention will last for two months and consists of seven sessions based on the 5A behavioral counseling model, with four in-person face-to-face sessions last

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes (FBS = 126 mg/dl or RBS = 200 mg/dl or HbA1c = 6.5%) with a history of diabetes for at least 5 years who have at least two of the following PAD risk factors: - Current smoking or a history of smoking for at least one year - History of hypertension (Hypertension = 130/80 mmHg) - Dyslipidemia, including: (HDL 25). Age between 40 to 75 years Absence of any disabling hearing, visual, or speech impairments Absence of severe cognitive impairment and awareness of person, time, and place Willingness to participate in the study Ability to communicate in Persian A patient who is two days away from hospital discharge.

Exclusion criteria

Exclusion criteria: Diagnosis of serious unrelated diseases that may affect study outcomes, including:Advanced systolic/diastolic heart failure (Class III and IV) according to the New York Heart Association (NYHA) classification-Severe acute or chronic infectious diseases-Diagnosis of psychiatric disorders requiring active treatment Diabetes exacerbation requiring immediate/emergency interventions, such as diabetic ketoacidosis or recurrent severe hypoglycemia Diagnosis of advanced peripheral artery disease (PAD) requiring surgery or advanced interventions such as angioplasty Need for dialysis during the study Participation in other similar interventional programs such as rehabilitation and self-care or self-monitoring diabetes education Need for invasive interventions (e.g., cardiac surgery, percutaneous coronary intervention (PTCA), organ transplantation such as liver, kidney, or heart) Alcohol or drug dependency during the study Life expectancy of less than six months Pregnancy Issues related to adherence to the current intervention, including:Failure to attend at least two counseling sessions-Withdrawal from the study due to personal or voluntary reasons (e.g., migration or relocation)

Design outcomes

Primary

MeasureTime frame
Physical Function. Timepoint: Before the intervention. Method of measurement: International Physical Activity Questionnaire - Short Form (IPAQ-SF).;Self-Management. Timepoint: Before the intervention. Method of measurement: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R).

Secondary

MeasureTime frame
Glycemic Control. Timepoint: Before the intervention. Method of measurement: Glucometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArya Sharafi

Khoram-Abad University of Medical Sciences

sharafiarya@gmail.com+98 66 3340 4443

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026