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临床试验/NCT05766215
NCT05766215尚未招募不适用

Influence of Nurse-led Therapeutic Patient Education on Glycemic Control and Knowledge of Patients With Type 1 Diabetes Mellitus in Hospital Transition: a Quasi-experimental Trial

Hospitales Universitarios Virgen del Rocío2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
13
试验地点
2
主要终点
Height

研究概览

简要总结

The goal of this interventional quasiexperimental study is to learn about the influence of therapeutic education carried out by nurses in the management and knowledge of patients with T1DM. Participants will be:

Given several therapeutic education sessions. Evaluated using different questionnaires and anthropometric measures.

详细描述

The main objective of the study will be to determine the influence of therapeutic education carried out by nurses in the management and knowledge of patients with T1DM who will make a hospital transition. The research design will be a single-blind, nonrandomized, quasi-experimental, single-center, 1-group controlled study .

It will be developed at the Center for Diagnosis and Treatment (CDT) of the Virgen del Rocío University Hospital (HUVR), in Seville (Spain). The participant selection process will be carried out considering that only 13 adolescents 17 and 18 years and younger with T1DM, belonging to the reference hospital area, will transit from the Children's Hospital to the Adult Hospital. It is estimated that the study will have a sample of a minimum of n=10, which will be studied over 12 months.

Given the existing bibliography about the benefits of this intervention , 1 it is expected that the glycosylated hemoglobin (HbA1c) of patients will be less than 7%, which together with the Self-Management Adherence Questionnaire for Diabetes Treatment (SCI-R. es) 2 represents that patients perform adequate management of their disease. The Survey of Eating Problems in Diabetes Summary Questionnaire (EPAD-R) 3 will be used to assess their eating behavior. An improvement in people's knowledge regarding hypoglycemia is also sought, measured with the Clarke test 4 ; and an improvement in the quality of life, measured with the SF-12 questionnaire 5 and family support with the Apgar test 6 .

The therapeutic plan consists of preparing the process prior to discharge from the pediatric center, transferring to the adult hospital with a clinical and educational report and a previously arranged visit to the new unit. The heads of both teams coordinate the structure and the transition process with regular meetings. From the Adult Diabetes Day Hospital, a joint visit is reserved with the endocrinologist and the nurse educator. They are integrated into a 12-month therapeutic care and education program. It consists of four structured phases: 1. Welcome nurse visit, 2. Diabetologic education course adapted to the detected needs, 3. Individualized follow-up through alternating quarterly appointments between nurses and endocrine physician, 4. Evaluation and discharge of the program.

At the beginning (baseline visit), at 3 and 12 months the following variables are recorded:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age 17 years.

排除标准

  • Unable to give informed consent.

结局指标

主要结局

Height

时间窗: 12 months

cm

Glycated hemoglobin.

时间窗: 12 months

HbA1c

Coefficient of variation

时间窗: 12 months

CV

Time below range

时间窗: 12 months

TBR

Glucose Management Indicator

时间窗: 12 months

GMI

Weight

时间窗: 12 months

Kg

Body Mass Index

时间窗: 12 months

BMI

Time above range

时间窗: 12 months

TAR

Time in Range

时间窗: 12 months

TIR

次要结局

  • Adherence to diabetes treatment(12 months)
  • Perception of symptoms of hypoglycemia(12 months)
  • Eating behavior,(12 months)
  • Perception of quality of life.(12 months)

研究者

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pilar Santa Cruz Álvarez

Enfermera de Práctica Avanzada (EPA)

Hospitales Universitarios Virgen del Rocío

研究点 (2)

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