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临床试验/NCT04722289
NCT04722289已完成不适用

The Together on Diabetes Intervention

Center for Diabetes, Copenhagen Municipality0 个研究点目标入组 20 人开始时间: 2017年12月1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
20
主要终点
Baseline, diabetes medication adherence

研究概览

简要总结

The Danish healthcare system is universal and free of charge for Danish citizens, as all healthcare services are financed by general taxes. However, socioeconomic differences exist in access to healthcare services, treatment, and consequences of type 2-diabetes (T2D).

Using a realistic evaluation approach, this study aimed to evaluate the implementation of a Danish peer support intervention, targeted on improving self-management and use of healthcare services among socially vulnerable people with type 2-diabetes ("peers"). The study focused on the mechanisms generating the intended outcomes. Further, how contextual factors in peers' everyday life facilitated or hindered the mechanisms to operate.

The study design is a multi-method case study (n=9). Data include qualitative semi-structured interviews with four key groups of informants (peer, peer supporter, project manager, and a diabetes nurse). Each type of informant per case was interviewed (n=25) to obtain different perspectives of how the peers' interacted, and benefited from the intervention. All interviews were completed immediately after the after the 6-month intervention.

Further, a quantitative survey was conducted among peers at baseline (N=9) and follow-up (N=9) to obtain information about how peers' individual contextual factors, such as their sociodemographic characteristics, co-morbidity, diabetes complications, social relations, and other life events influenced how they perceived and interacted in the intervention. Further, to measure improvements in their diabetes-self management (DSM) and use of healthcare services (outcomes). Questions from the Danish National Health Survey were used to measure DSM: (eating habits, physical activity,and medication intake). Use of healthcare services was measured by the number of times (during a 12-month period) the peers' attended diabetes controls at the GP; food therapist, and ophthalmologist or had other form of contacts with relevant health care services.

All data were collected between February 2018 and April 2020.

Hypothesis: 6-month individual face-to-face peer support provided by non-professional persons with T2D can improve self-management and use of healthcare services among socially vulnerable people with T2D if contextual factors such as peers' sociodemographic characteristics, health condition, and social relations facilitate their engagement in the intervention. Potential mechanisms that generate the expected outcomes might be: peers' motivation, trust, perceived beliefs and needs; and experience of being supported by the peer supporters.

详细描述

The intervention consists of five components: Recruitment of peers and peer supporters; training of peer supporters; match making of peers and peer supporters; individual face-to-face meetings between peers and peer supporters; and ongoing supervision and network meetings for peer supporters. The peer support meetings are held approximately every second week for six months and contain three activities: 'Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criteria:
  • •Poorly regulated T2D
  • •multi-morbidity
  • •no employment
  • •low/no education
  • •no contact to the healthcare system
  • •living alone with no/spare social network.

排除标准

  • •Poor regulated mental disease.
  • •Peer supporters
  • •Inclusion criteria:
  • •Well-regulated T2D
  • •Basic knowledge about T2D and the Danish healthcare system;
  • •Good communication skills
  • •An interest in supporting a socially vulnerable person with T2D
  • •Available two hours every second week for at least six-month (the intervention period).

研究组 & 干预措施

Together on Diabetes

Experimental

The intervention consists of five components: Recruitment of peers and peer supporters; training of peer supporters; matching peers and peer supporters; individual face-to-face meetings between peers and peer supporters; and ongoing supervision and network meetings for peer supporters.

干预措施: Together on Diabetes (Behavioral)

结局指标

主要结局

Baseline, diabetes medication adherence

时间窗: Assessed among peers before study participation, at 0 month

Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data

Change from Baseline, diet habits at 6 month

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the peers' diet habits (self-reported), Questionnaire data

Baseline, physical activity (training)

时间窗: Assessed among peers before study participation, 0 month

Peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data

Baseline, Use of healthcare services (diabetes controls at the GP)

时间窗: ssessed among peers before study participation, 0 month

Number of diabetes controls at GP (self-reported), Questionnaire data

Change from baseline, use of healthcare services (diabetes controls at the foot therapist)

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the number of diabetes controls at the food therapist) (self-reported), Questionnaire data

Baseline, diet habits

时间窗: Assessed among peers before study participation, 0 month

Peers' diet habits (self-reported), Questionnaire data

Baseline, physical activity (everyday activities)

时间窗: Assessed among peers before study participation, 0 month

Peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data

Change from Baseline, physical activity (everyday activities) at 6 month

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data

Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist )

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data

Change from Baseline, physical activity (training) at 6 month

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data

Baseline, use of healthcare services (diabetes controls at the ophthalmologist )

时间窗: Assessed among peers before study participation, at 0 month

Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data

Change from baseline, use of healthcare services (diabetes controls at the GP)

时间窗: Assessed among peers after study participation, at 6 month

Improvements in the number of diabetes controls at the GP (self-reported), Questionnaire data

Baseline, use of healthcare services (diabetes controls at the foot therapist)

时间窗: Assessed among peers before study participation, at 0 month

Number of diabetes controls at the food therapist) (self-reported), Questionnaire data

次要结局

未报告次要终点

研究者

发起方
Center for Diabetes, Copenhagen Municipality
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Stine Garn

Evaluator, PhD

Center for Diabetes, Copenhagen Municipality

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