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临床试验/NCT04688359
NCT04688359已完成不适用

Nurse-coordinated Follow-up Program in Primary Care: a Mixed-method Complex Intervention Feasibility and RCT Pilot Trial Among People at Risk for T2DM.

University of Akureyri2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
Cardiovascular Risk Factors changes up to one year after an intervention

研究概览

简要总结

Previous Icelandic studies regarding prevalence of diabetes have mostly used data from the capital area. Information on the proportion of people at risk at developing T2DM or having undiagnosed T2DM among people living in rural Northern Iceland is unknown. Clinical guidelines recommend that patients with prediabetes (diabetes warning signs) should be referred to a counselling program. The study will evaluate effectiveness of nurse-coordinated Guided Self-Determination (GSD) follow up program toward health promotion, for people at risk of T2DM.

详细描述

Prevalence of type 2 Diabetes Mellitus (T2DM) a major health problem is rising. This metabolic disease characterized by the inability to effectively metabolize glucose, and often also a silent and sneaky onset. A lag is often found between diagnose and onset of the disease. Diabetes related complications are expensive for the society, and reduce quality of life for the individual.

Around one out of three with T2DM in an Icelandic study were unaware of their T2DM when fasting blood glucose was measured. In the U.S.A., the average interval between onset of the disease and diagnose is seven years, and the authors claimed that 30% of people with T2DM are undiagnosed, with increased risk for chronic diabetes complications higher Cardiovascular risk factors (CVR), and higher premature death for people with early onset of T2DM compared to late onset of T2DM.

Research have shown 1.83-fold higher risk of CVD for those with prediabetes and 2.26-fold higher risk for individuals with undiagnosed diabetes compared to individuals with normal HbA1c. These results highlight the pivotal need to prevent development of diabetes, as there is an association between increased obesity and increased prevalence of T2DM as Type 2 diabetes (T2DM) is also found to be a major risk factor for cardiovascular diseases.

Icelandic people and especially men are becoming more overweight. From the years 1968-2012, body mass index (BMI) increased by 11%, from 25.8 kg/m2 to 28.7 kg/m2 for men between 50-69 years. In women 50-69 years, the BMI increased from 25.2 kg/m2 to 27.2 kg/m2, or 8%. These results highlight the pivotal need to prevent development of diabetes in Iceland, as there is an association between increased obesity and increased prevalence of type 2 Diabetes Mellitus (T2DM).

A Guided Self-Determination (GSD) is based on a strong theoretical value and is a well establish nurse-led interventional method for people diagnosed with T2DM and other diseases. To our knowledge this is the first time that GSD is used in Iceland. Nurses working in primary care, at The Health Care Institution of North Iceland (HSN), in Akureyri, Husavik and Sauðarkrokur, will offer the GSD intervention. Before the intervention the nurses will receive teaching and consultation from an experienced GSD diabetic nurse. During their use of the GSD method they will have counseling from the experienced GSD nurse and the PhD student. A systematic review claimed, that multi-professional interventions are more effective in improving diabetes care compared to single professional interventions.

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
Single (Participant)

盲法说明

The participants is informed of two groups but not which group he is allocated in.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • two of three:
  • BMI ≥ 30 kg/m2,
  • score ≥ 9 on FINDRISC,
  • HbA1c level ≥ 42 mmol/mol.
  • Non-blood-glucose-lowering medical treated T2DM.

排除标准

  • People diagnosed with Diabetes at strart-point.

结局指标

主要结局

Cardiovascular Risk Factors changes up to one year after an intervention

时间窗: 0- 6 months and 1 year

Changes for each participant from Baseline to endpoint on CVR factors, changes of risk measured in percentages (%) compared to normal risk in the Icelandic population from beginning to end of intervention. Using the Icelandic cardiovascular risk factor calculator.

Measurements behind the Icelandic heart association risk calculator

时间窗: 0- 6 months and 1 year

Changes from baseline to endpoint: * Weight and height (will be combined to report BMI in kg/m\^2) * Systolic blood pressure: In mm hg * Cholesterol: in mmol/L * HDL-Cholesterol: in mmol/L * Triglycerides measurements: in mmol/L, * Regular physical activity: yes/no * Smoking: never, stopped, 1/2 pack or less a day, 1/2 to 1 pack a day, 1 pack or more * Do you have diabetes: yes/no, * Do gender parents, brothers or sisters of same parents, have cardiovascular diseases : Yes/No

次要结局

  • Changes in HbA1c level(0- 6 months and 1 year)
  • EQ-5D-5L Questionnaire of self rated health.(0- 6 months and 1 year)
  • Health Literacy (HL) questionnaire Icelandic version: HLS-EU-Q16IS.(0- 6 months and 1 year)
  • Hip-to-Waist ratio(0- 6 months and 1 year)
  • FINDRISC risk score "Diabetes Risk Score questionnaire"(0- 6 months and 1 year)
  • WHO-5 Quality of Life (QoL) questionnaire(0- 6 months and 1 year)

研究者

发起方
University of Akureyri
申办方类型
Other
责任方
Sponsor

研究点 (2)

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