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临床试验/NCT03678896
NCT03678896已完成不适用

Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial

Associacao Protectora dos Diabeticos de Portugal0 个研究点目标入组 49 人开始时间: 2017年1月5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
49
主要终点
Change from baseline in hemoglobin A1c levels at 6 months

研究概览

简要总结

This study is related to the development of a new model of Group Care for patients with Diabetes - the CrewD Program, incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention.

详细描述

A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Only patients with type 2 diabetes of >1 year known duration, aged < 85 years were included in the intervention.

排除标准

  • •Patients that did not complete the four assessments.

研究组 & 干预措施

CrewD Program approach

Experimental

The aim was to increase education about the disease by using narrative skills through the CrewD Program. The sessions were conducted by two group leaders: a health professional and a literature professor manager of creative writing groups.

Each session had a title, which parallels the classical structured educational approach (active comparator condition), which was known in advance by the subjects: a) Who I am in Diabetes?; b) Nutrition; c) The body where I live; d) Fears; e) Can attention change things?; and f) Roots.

Team leaders directed a discussion of different texts used in the sessions with the participants focusing on their feelings and on how the texts relate to themselves and to their diabetes. Patients were encouraged to participate and freely express their opinion.

干预措施: CrewD Program (Behavioral)

Classical structured education

Active Comparator

Each session was 90 minutes long, with a similar internal structure in all of them. Each session included the following topics: a) Chronic Disease; b) Nutrition; c) Exercise; d) Complications; e) Self-management; and f) Diabetic foot. The sessions were held in a large room, in which the seats were arranged in circle. Every session was chaired by two healthcare providers, who worked as group leaders.

There was a different visual presentation in each session, with relevant theoretical information. A board with sheets of paper was available for use in the discussion along with brochures about the disease.

Patients were encouraged to actively participate and take part in group-problem solving. Group leaders guided the discussion by asking questions and encouraging the discussion.

干预措施: Classical structured education (Behavioral)

结局指标

主要结局

Change from baseline in hemoglobin A1c levels at 6 months

时间窗: Up to 6 months

Hemoglobin A1c is measured in mmol/mol units.

次要结局

  • Change from baseline in weight at 6 months(Up to 6 months)
  • Change from baseline in fat mass at 6 months(Up to 6 months)
  • Change from baseline in self-reported health(Up to 6 months)
  • Change from baseline in self-reported empathy at 6 months(Up to 6 months)
  • Change from baseline in self-reported group satisfaction at 6 months(Up to 6 months)
  • Change from baseline in waist circumference at 6 months(Up to 6 months)
  • Change from baseline in self-reported quality of life at 6 months(Up to 6 months)
  • Change from baseline in self-reported locus of control at 6 months(Up to 6 months)

研究者

发起方
Associacao Protectora dos Diabeticos de Portugal
申办方类型
Other
责任方
Sponsor

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