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临床试验/NCT06113588
NCT06113588Enrolling By Invitation不适用

Improving Transition of Care in Type 1 Diabetes Mellitus: A Collaborative Approach

Northern Sydney and Central Coast Area Health Service1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
80
试验地点
1
主要终点
Patient self-efficacy (patient, family and staff member) relating to diabetes

研究概览

简要总结

This research project seeks to address the question of how to improve the transition of patients with type 1 diabetes mellitus from the paediatric to the adult health service at RNSH and Mona Vale Community Health Centre (seeking the perspectives of patients, families, and staff)?

详细描述

There are significant limitations in the literature relating to transition from paediatric to adult healthcare.

In healthcare, transition describes the purposeful process of planning and moving from paediatric to adult services and usually occurs in adolescence (in itself a time of rapid physical, cognitive and psychosocial growth between childhood and adulthood). The available evidence within the literature to guide this process of transition is often limited and additional evidence to guide clinical practice is required. Although reports within the literature vary, it is known that up to 50% of young adults with an endocrine disorder are lost to follow-up after transition to adult health services. Even if the young person attends the adult service, they may have poor health outcomes related to inability to self-manage their condition, particularly if it is a chronic disease requiring significant daily intervention by the patient, such as in type 1 diabetes mellitus.

Type 1 diabetes mellitus is a life-long condition characterised by autoimmune-mediated destruction of pancreatic β-cells, almost always resulting in absolute insulin deficiency. As a result, patients are required to perform lifelong intensive glucose monitoring and insulin administration. These intensive insulin regimens require an enormous amount of attention and effort on the part of the young person with diabetes and their family, but dramatically reduce their rates of micro- and macro-vascular complications, such as blindness, kidney failure, heart attack and stroke. Evidence for this 'legacy effect' - the long-term clinical benefits of early intensive insulin treatment - are provided through studies including the EDIC (Epidemiology of Diabetes Interventions and Complications) study which undertook long-term follow up of the Diabetes Control and Complications Trial (DCCT). The DCCT, conducted from 1983-1989, randomised 1441 participants with new or recently-diagnosed type 1 diabetes to receive either intensive insulin therapy or standard therapy. The DCCT/EDIC study ultimately recommended maintaining patients' glucose levels as close to the normal range as safely possible, with intensive insulin therapy and monitoring.

Glycaemic control and transition in adolescents with type 1 diabetes mellitus has its own specific challenges. Across all age groups, adolescents are currently the farthest from achieving good glycaemic control (a HbA1c goal of <58 mmol/mol or 7.0%). The factors contributing to this may include hormonal changes during puberty, psycho-social challenges and decreased adherence to insulin therapy regimens.

Appropriate transition of patients with type 1 diabetes from paediatric to adult health care thus needs to take a holistic approach to the individual patient which addresses these factors and which is centred on individual patients' developmental stages and circumstances.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents who have an existing diagnosis of type 1 diabetes mellitus and who underwent (in 2020 to 8th June, 2023) or who are undergoing (from 9th June, 2023 and subsequent cohorts) transition from paediatric care to adult health care at Royal North Shore Hospital and Mona Vale Community Health Centre. Adolescents with type 1 diabetes will be 16 years or older
  • A family member or caregiver of the participant of the adolescent patient with type 1 diabetes mellitus
  • A staff member who is a member of the patient's treating diabetes team within the paediatric diabetes service (first study visit and second study visit) and young adult diabetes service (third study visit)

排除标准

  • There are no specific exclusion criteria

结局指标

主要结局

Patient self-efficacy (patient, family and staff member) relating to diabetes

时间窗: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

From prospective questionnaires, with higher scores indicative of higher self-efficacy

Diabetes knowledge questionnaire (patient and family member)

时间窗: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

From prospective questionnaires, with a single correct answer per question

Diabetes-related distress (patient and family member)

时间窗: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

From prospective questionnaires, with higher scores indicative of higher distress levels

次要结局

  • Patient medical outcomes(From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shihab Hameed

Principal Investigator

Northern Sydney and Central Coast Area Health Service

研究点 (1)

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