A Cluster Randomized Trial to Investigate the Impact of a Type 2 Diabetes Risk Prediction Model on Change in Physical Activity Within Routine Health Checks in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Difference of participant's physical activity at twelve months after the routine health check between the groups.
研究概览
简要总结
Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient's behavior, perceived risk of persons, shared-decision making and particularly on patient´s health. The aim of this study is to investigate the impact of a non-invasive diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
详细描述
Diabetes risk scores are predictive models to estimate the probability for an individual to develop diabetes within a defined time period. In the last years, many diabetes risk prediction models were developed worldwide. It has been proposed that using diabetes risk scores as first step of diabetes screening is more practical than blood glucose tests as the latter are time consuming and costly. Given the rapid development of diabetes risk scores and a simultaneous reluctance of primary care physicians (PCPs) to implement diabetes risk scores in everyday practice, there is an urgent need to expand our knowledge of the impact of diabetes risk scores in the primary health care setting. Thus, the aim of the study is to investigate the impact of a non-invasive risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for participation of medical practitioners:
- •general practitioners, medical practitioners and internists working as general practitioners with and without further training in diabetology according to German Diabetes Association standards
- •provide the routine health check
排除标准
- •for participation of medical practitioners:
- •treat exclusively patients with private insurance
- •treat exclusively diabetes patients in a specialized medical practice
- •Inclusion criteria for participation of participants
- •appointment for the routine health check
- •insured in statutory health insurance
- •age > 35 years
- •Body Mass Index (BMI) of ≥ 27 kg/m2
- •Exclusion criteria for participation of participants
- •type 1 or type 2 diabetes diagnosis or already abnormal blood glucose level (fasting glucose ≥ 126 mg/dl or 2 hours oral glucose tolerance test (oGTT) ≥ 200mg/dl or glycated hemoglobin (HbA1c) ≥6,5%) before the routine health check
- •no sufficient German language skills to fill in the questionnaires
- •presence of an incurable disease with a prognosis of less than one year
- •severe mental illness or dementia
- •severe underlying disease, which largely impairs physical activity
- •pregnancy
- •participation in another clinical study 30 days before study inclusion
结局指标
主要结局
Difference of participant's physical activity at twelve months after the routine health check between the groups.
时间窗: at baseline, 6 and 12 months follow-up
Self-reported outcome, international validated questionnaire Physical Activity Questionnaire Short Last 7 Days Format (IPAQ-SF), which has been shown to be a reliable and valid tool to obtain comparable estimates of physical activity.
次要结局
- Improvement of shared decision making, assessed by participants.(at baseline)
- Improvement of shared decision making, assessed by PCPs.(at baseline)
- Change in Body-Mass-Index (BMI)(at baseline, 6 and 12 months follow-up)
- Change in participant's level of depression and anxiety.(at baseline, 6 and 12 months follow-up)
- Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice.(at baseline, and up to one year after the PCP entered the study)
- Improvement in the counseling process assessed by PCPs.(at baseline and up to one year after the PCP entered the study)
- Improvement in the counseling process assessed by participants.(at 6 months follow-up)
- Improved motivation to change lifestyle, assessed by participants.(at baseline, 6 and 12 months follow-up)
- Change in participant's quality of life.(at baseline, 6 and 12 months follow-up)
- Change of participant's perceived risk of developing diabetes.(at baseline, 6 and 12 months follow-up)
- Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice.(at 6 months follow-up)
研究者
Wolfgang Rathmann
PD Dr. Wolfgang Rathmann MSPH (USA)
German Diabetes Center