Effectiveness of a Transtheoretical Model-Based Foot Care Program in Improving Foot Care Behaviors and Self-Efficacy in Adults With Type 2 Diabetes: An Assessor-Blinded Randomized Controlled Trial
Determining and comparing the stage of behavior change, self-efficacy and score of self-care activities of diabetic patients before and 2 months, 6 months after the intervention in the experimental and control groups in adults with type 2 diabetes
Design
120 eligible diabetic patients of Korane Comprehensive Health Center are selected by non randomized sampling method. Then, based on the convenience sampling method, 60 people in the intervention group and 60 people in the control group are allocated in parallel and unblinded.
Settings and conduct
Adult type 2 diabetes patients are listed in Kurane comprehensive health centers of Qazvin province. Based on sample size and convenient method, patients are divided into intervention and control groups without blinding.
Participants/Inclusion and exclusion criteria
Adult patients with type 2 diabetes who have consent to participate in the study and do not have any acute, psychiatric or foot ulcers. Not having a history of recent training for foot ulcers
Intervention groups
The intervention of the training program for all patients in intervention group is based on the stages of behavior change. The intervention is carried out in person in 4 one-hour training sessions during 1 month, and the questionnaires are provided to the patients again in the period of 2 and 6 months.
Main outcome variables
Behavioral stage according to transtheoretical model; diabetes self-efficacy score; Diabetes self-care score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230112057116N2
Registration date:2024-04-02, 1403/01/14
Registration timing:prospective
Last update:2024-04-02, 1403/01/14
Update count:0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Peigham Heidarpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4156
Email address
pheidarpoormd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-14, 1403/01/26
Expected recruitment end date
2024-05-15, 1403/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a Transtheoretical Model-Based Foot Care Program in Improving Foot Care Behaviors and Self-Efficacy in Adults With Type 2 Diabetes: An Assessor-Blinded Randomized Controlled Trial
Public title
Effectiveness of a Transtheoretical Model-Based Foot Care Program in Improving Foot Care Behaviors and Self-Efficacy in Adults With Type 2 Diabetes: An Assessor-Blinded Randomized Controlled Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes patients who have been approved by the doctor of the center and registered in the Sib system.
Consent to participate in the study
Exclusion criteria:
The existence of a problem that causes withdrawal from the study (acute illness, surgery, having diabetic foot ulcer at the time of study.. etc.)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commitee of school of medical education of Shahid Beheshti University of medical sciences
Street address
, Toraj allay, Valiasr street,
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.SBMU.SME.REC.1402.078
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Diabestes Management self efficacy scale
Timepoint
Before the intervention, two months and six months after the intervention
Before the intervention, two months and six months after the intervention
Method of measurement
Prochaska questionnaire
3
Description
diabetes self care scale
Timepoint
Before the intervention, two months and six months after the intervention
Method of measurement
Summary of Diabetes Selfcare Activity Measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational intervention based on the resources of the "Diabetic Foot Patients Clinical Pathway "compiling the health guide for the summer of 2021with educational topics: Diabetic foot screening and examination, principles of prevention of diabetic foot ulcers, risk classification system for diabetic foot ulcers And the preventive screening interval is based on the IWGDF, another educational resource is the Self-Care Guide for Family Health Ambassadors, Diabetic Foot Care. The intervention is conducted face-to-face during 1 month in 4 one-hour training sessions (one session per week). The first session: General diabetes, types of diabetes and the criteria for diagnosing diabetes. The second session: Treatments for diabetes, the purpose of treatment and the complications of diabetes. The third session: knowing the risk factors of the diabetic foot and the necessity of preventing diabetic foot ulcers. The fourth session: principles of diabetic foot care. Educational sessions are held in the form of slide shows and questions and answers at the designated comprehensive health center.
Category
Behavior
2
Description
Control group: Routine training conducted in comprehensive health centers
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurane comprehensive rural health service center in Qazvin city