Interviewing Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline behavioral skills level of adolescents at 6 months
研究概览
简要总结
Aim: To evaluate the effects of information-motivation-behavioral skills model interventions given by nurses during home visits on the knowledge levels, personal and social motivation levels, behavioral skills, and HbA1C levels of adolescents with poor glycemic control.
Design: Randomized controlled study. Methods: 50 adolescents with type 1 diabetes were equally divided into study and control groups. Socio-Demographic Form, Diabetes Information Evaluation Form, The Child Attitude Toward Illness Scale, The Multidimensional Scale of Perceived Social Support, and Diabetes Management Self-Efficacy Scale were utilized in data collection. The scales were administered at the beginning of the study and six months later. HbA1c levels of adolescents were evaluated in the third and sixth months. Multiple home visits and phone calls were made to each participant in the intervention group. Interventions to improve the information-motivation-behavioral skills model-based knowledge, personal and social motivation, and behavioral skills were applied during the home visits.
详细描述
Aims The aim of the study was to evaluate the effects of IMB model interventions conducted by nurses during home visits on the knowledge levels, personal and social motivation levels, behavioral skills, and HbA1c levels of adolescents with T1DM. The study also aimed to test the following hypotheses: T1DM adolescents who experienced an IMB model-based intervention during a home visit will have more knowledge (H1) and more positive attitudes (H2) about their disease, higher levels of perceived social support (H3), higher levels of self-efficacy (H4), and lower levels of HbA1c (H5) than the control group Design A randomized controlled experimental study was conducted to test the hypotheses above and explore the aforementioned aim.
Sample/Participants The study was conducted with patients (n=50) of the Pediatric Endocrine Clinic of the Ankara Pediatric Hematology Oncology Training and Research Hospital between October 2018 and August 2019. The researchers evaluated the results of T1DM adolescents with HbA1c measurements at the clinic for 4 months and included those who met the inclusion criteria. The inclusion criteria were: (1) a T1DM diagnosis established at least six months ago, (2) an HbA1c level of >7.5, (3) not using insulin pumps, (4) the absence of any chronic disease other than diabetes, (5) attending follow-up visits at the clinic once every three months, and (6) living in Ankara. Adolescents were included in the study after an assessment of the HbA1c level. Adolescents who met the inclusion criteria were then grouped into study (n=25) and control (n=25) groups in order of arrival at the clinic, using stratified randomization by gender to ensure homogeneity.
The sample size was calculated based on the mean HbA1c level and standard deviations in the two groups in the power analysis made at the end of the research. An independent sample t-test was used to establish the 1.4-unit difference in mean HbA1c levels, and a power of 99.107% was achieved.
Data Collection The Sociodemographic Information Form prepared by the researcher consisted of six items regarding sociodemographic data and information on the participants.
Diabetes Information Evaluation Form (DIEF), Child Attitude toward Illness Scale (CATIS), Multidimensional Scale of Perceived Social Support (MSPSS), and Diabetes Management Self-Efficacy Scale (DMSES) were used to evaluate the components of the IMB model, and on the assessment of HbA1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-18 age An HbA1c level of ≥7.5
排除标准
- •Diagnosed within the last 6 months An HbA1c level of ˂7.5 Using insulin pumps Having chronic diseases other than diabetes Living in another city Declining to participate
结局指标
主要结局
Change from baseline behavioral skills level of adolescents at 6 months
时间窗: immediately before intervention and immediately after intervention
Diabetes Management Self-Efficacy Scale were used to evaluate Behavioral Skills. The instrument includes 26 items rated from 1 (strongly agree) to 5 (strongly disagree). A higher score indicates a lower level of self-efficacy.
Change from baseline social motivation level of adolescents at 6 months
时间窗: immediately before intervention and immediately after intervention
Social motivation evaluated by Multidimensional Scale of Perceived Social Support. The Multidimensional Scale of Perceived Social Support consists of 12 items and it is rated on a 7-point Likert-type scale.
Change from baseline personal motivation level of adolescents at 6 months
时间窗: immediately before intervention and immediately after intervention
Personal motivation evaluated by Child Attitude toward Illness Scale. The nine items of the Child Attitude toward Ilness Scale are rated on a 5-point Likert-type scale.
Change from baseline HbA1c levels of adolescents at 6 months
时间窗: immediately before intervention, at month 3 and immediately after intervention
Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control
Change from baseline knowledge level of adolescents at 6 months
时间窗: immediately before intervention and immediately after intervention
Information evaluated by Diabetes Information Evaluation Form.The total information score was calculated over 20 points, with 1 point given for correct answers and 0 points to missing or wrong answers.
次要结局
未报告次要终点
研究者
Elif Bakır
DR. Principal Investigator
Hacettepe University