The Effect of Family Support on Diabetes Patients' Health Beliefs, Behavioral and Metabolic Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hensarling's Diabetes Family Support Scale
研究概览
简要总结
This study, designed according to the randomized pre-test and post-test control group experimental model, will be carried out with the patients who apply to the Diabetes Education Unit of Samsun Training and Research Hospital The universe of the study will consist of adult patients between the ages of 20-65 among the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit.
The sample of the study will consist of 100 diabetic patients who comply with the selection criteria and volunteer to participate in the study. The average scores of Hensarling's Diabetes Family Support Scale in Diabetes Patients were determined as 64.12, with an error margin of %5% and a 95% confidence interval, with a sample size of 80% with a sample size of 35 patients for each group, a total of 70 patients.
Considering the participant losses during the project, 50 diabetic patients (experiment = 50, control = 50) for each group were determined as a total sample group of 100 diabetic patients with 50% reserve. Personal questionnaire prepared by the researcher in line with the literature, Health Belief Model Scale in Diabetes Patients, Hensarling's Diabetes Family Support Scale and Diabetes Attitude Scale will be used. The purpose of the study will be explained to the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit and the study will be carried out with diabetic patients who agree to participate in the study. Diabetes patients will be divided into experimental and control groups by Simple Random Method. A training program will be applied to the diabetic patient and their family members included in the experimental group. After the training, a reminder text message will be sent to their phones twice a week for three months and they will be called once a month. Three months after the end of the training, the control will be called for examination.
详细描述
This study focuses on the effect of family support on diabetes management by using the Health Belief Model. This work; The health belief model, which is a human behavioral model, will comprehensively examine the effects of the planned diabetes education to be given to the diabetic patient together with the family member on the diabetes management of the diabetic patient.
Study design and environment The study is an experimental study with randomized controlled pre-test and post-test control group. The randomized clinical trial is based on guidelines recommended by Consolidated Standard of Reporting Trials - CONSORT 2010. The data of the study will be collected in the Diabetes Education Unit of Samsun Training and Research Hospital between January and June 2021.
As a pre-test for diabetic patients who applied to Samsun Training and Research Hospital Diabetes Education Unit and accepted to participate in the study; The questionnaire form prepared by the researcher in accordance with the literature, the Health Belief Model Scale in Diabetes Patients and Hensarling's Diabetes Family Support Scale will be applied. After the pretest application, they will be randomly assigned to the sample pool to be divided into experimental and control groups. Diabetes patients will be divided into experimental and control groups by simple random method. A questionnaire form prepared by the researcher in accordance with the literature and the Diabetes Attitude Scale will be applied to the family members of the diabetes patients in the experimental group.
Data Collection Tools Personal Information Form (for diabetic patients): This form, developed by researchers in accordance with the literature, is used by diabetic patients; It includes information about the disease such as age, gender, marital status, educational status, occupation, income status, duration of diabetes, history of other chronic diseases, diabetes treatment, alcohol-smoking, physical activity, nutrition, diabetes control interval.
Personal Information Form (for family member): This form, developed by researchers in accordance with the literature, consists of introductory features of the family member including gender, age, marital status, educational status, occupation, income, employment status, and relationship with a diabetic patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with Type 2 Diabetes in the last 6 months
- •Living in Samsun
- •Being between the ages of 20-70
- •HbA1c ≥ 6.5%
- •Understanding and speaking Turkish
- •Owning a smartphone and communicating with the phone
- •Having blood glucose measurement tools at home
- •Volunteering to participate in study with a family member of their choice
排除标准
- •Being pregnant
- •Having advanced or terminal disease (such as cancer, chronic kidney failure)
- •Using an insulin pump
- •Being disabled
结局指标
主要结局
Hensarling's Diabetes Family Support Scale
时间窗: 3 months
This scale determined 4 sub-dimensions of "Diabetes Family Support": empathic support (9 items), encouragement (7 items), facilitative support (6 items) and sharing support (2 items). A total of 24 questions are evaluated over 5 options. These options are "Never", "Almost Never", "Sometimes", "Most of the time", "Always". The lowest possible score for Hensarling's Diabetes Family Support Scale is zero (0) and the highest possible total score: ninetysix (96). The closer the Hensarling's Diabetes Family Support Scale total score is to the highest possible score of 96, the individual's perceived family support is expected. The closer the Hensarling's Diabetes Family Support Scale total score is to 0, the less family support is perceived. In the posttests, it is aimed to increase the score obtained from this scale.
Fasting Blood Glucose
时间窗: 3 months
Before the pre-tests, the fasting blood glucose value of diabetic patients will be recorded. For these measurements, the latest examinations made in the hospital will be used. It is expected that the HbA1c values of diabetic patients will decrease in the posttest at the end of the third month.
Health Belief Model Scale in Diabetes Patients
时间窗: 3 months
Health Belief Model Scale in Diabetes Patients: This scale; It is the "Health Belief Model Scale in Diabetes" form adapted by Tan in 2004 for Type 2 diabetes patients and adapted into Turkish in 2007 by Kartal and Ozsoy. The model in the scale has 5 sub-dimensions. In the evaluation of the scale, Likert type scoring with scale items between 1 and 5; "Strongly disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "strongly agree" (5). The scale consists of 33 items and five main sub-dimensions: perceived sensitivity (4 items), perceived severity (3 items), perceived usefulness (7 items), perceived barriers (9 items), and recommended health-related activities (10 items). A minimum of 33 and a maximum of 165 points can be obtained on the scale. In the posttest, it is aimed to increase the scale score in perceived sensitivity, perceived seriousness, perceived benefit and recommended activities related to health, and decrease the perceived barriers score.
HbA1c
时间窗: 3 months
HbA1c values of diabetic patients will be recorded before pre-tests. For these measurements, the latest examinations made in the hospital will be used. It is expected that the HbA1c values of diabetic patients will decrease in the posttest at the end of the third month.
Diabetes Attitude Scale
时间窗: 3 months
The seven subgroups covered by the scale are special education needs, attitude towards patient compliance, severity of type 2 diabetes, blood glucose control and complications, the effect of diabetes on the patient's life, attitude towards patient autonomy and attitude towards team care. Scale items were scored with Likert type scoring ranging from 1 to 5. Score\> 3 indicates positive attitude, score 3 indicates negative attitude. Increasing the score to 5 or decreasing to 1 strengthens the attitude in that direction. In the posttests, it is aimed to increase the diabetes attitude scale scores of family members in a positive way.
次要结局
未报告次要终点
研究者
Ilknur Aydin Avci
Head of Nursing Department
Ondokuz Mayıs University