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临床试验/NCT03703440
NCT03703440已完成不适用

Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2019年11月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
212
试验地点
2
主要终点
Hemaglobin A1c (HbA1c)

研究概览

简要总结

The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Among emerging adults with type 1 diabetes (T1D), the investigators aim to assess the effect of group education visits integrated into pediatric care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment.

详细描述

Rationale. The transition from pediatric to adult diabetes care is a challenging period for adolescents and emerging adults (ages 18-30 years) with type 1 diabetes (T1D). It is characterized by a deterioration in glycemic control (Hemoglobin A1c [HbA1c]), decreased adherence to self-management tasks and to clinic attendance and an increased risk of adverse outcomes. The investigators propose to examine group education visits as a potentially cost-effective approach. In emerging adults with T1D, the investigators hypothesize that group education visits, as compared with usual care, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes after the transfer to adult care.

Primary Aim. To determine the impact of group educations visits, compared with usual care, on HbA1c after the transfer to adult care.

Secondary Aims. 1. To determine the impact of group education visits, compared with usual care, on time between last pediatric and first adult T1D visit (gap > 6 months), emergency department (ED) visits and hospitalizations, severe hypoglycemic events, stigma, self-efficacy, disease knowledge, transition readiness, quality of life (QOL) and diabetes distress, after the transfer to adult care. 2. To determine the cost-effectiveness of group education visits.

Methods. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Patients will be recruited over 24 months. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio . Visits in the active arm will consist of a group education session followed by an individual appointment with the diabetes care physician every 3-months. The group education session, facilitated by a diabetes nurse educator or dietitian, will consist of a patient-driven discussion on topics relevant to adolescents with T1D. Patients in the control group, will have in parallel with the intervention group, individual appointments with their diabetes provider as per usual care. The primary outcome is the change in HbA1c measured at 24 months (HbA1c measured at 24 months - HbA1c measured at baseline). Secondary outcomes are delays in establishing adult T1D care (Y/N), T1D-related hospitalizations and ED-visits (rates/P-Y), severe hypoglycemic events, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, and QOL. Assessments are at baseline, 12 and 24 months . Analysis will be by intention to treat. Outcomes will be calculated and compared between the two trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis.

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
Single (Outcomes Assessor)

盲法说明

Data analysts

入排标准

年龄范围
16 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Adolescents with a diagnosis of Type 1 Diabetes
  • •16 to 17 years of age
  • •Receiving diabetes care at one of two university teaching hospital-based pediatric diabetes clinics in Montreal: Montreal Children's Hospital (MCH) or Centre Hospitalier Universitaire Sainte Justine (CHUSJ)
  • •Fluent in English or French

排除标准

  • •Severe neurocognitive disabilities that may preclude patient's ability to participate in a group education visit
  • •Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

研究组 & 干预措施

Active

Experimental

≥3 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment.

干预措施: Active arm (Other)

Control

Other

Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer.

干预措施: Control arm (Other)

结局指标

主要结局

Hemaglobin A1c (HbA1c)

时间窗: 0, 12, 24 months

HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test

次要结局

  • Delay in establishing adult Diabetes Care (days)(24 months)
  • Stigma(0,12, 24 months)
  • Cost effectiveness (HbA1c)(12 and 24 months)
  • Diabetes knowledge(0, 12, 24 months)
  • Delay in establishing adult Diabetes Care (gap in care>6 months)(24 months)
  • Diabetes-related hospitalizations(0, 12, 24 months)
  • Diabetes-related emergency department visits(0, 12, 24 months)
  • Severe hypoglycemic events(0,12, 24 months)
  • Self-efficacy(0,12, 24 months)
  • Transition readiness(0, 12 months)
  • Cost effectiveness (QOL)(12 and 24 months)
  • Diabetes distress(0, 12, 24 months)
  • Quality of life (Generic Core)(0, 12, 24 months)
  • Quality of life (Diabetes Module)(0, 12, 24 months)
  • Cost effectiveness (self-efficacy)(12 and 24 months)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meranda Nakhla

Assistant Professor, Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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