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临床试验/NCT03261895
NCT03261895已完成不适用

Effectiveness of a Nurse-led Integrative Health and Wellness (NIHaW) Programme on Behavioural, Psychosocial and Biomedical Outcomes Among Individuals With Newly Diagnosed Type 2 Diabetes: A Randomised Controlled Trial

Chinese University of Hong Kong4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年5月4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
入组人数
128
试验地点
4
主要终点
Self-management

研究概览

简要总结

This randomized controlled trial aims to investigate the effectiveness of an integrative medicine (traditional Chinese medicine and western medicine) based structured education programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study is based on the health belief model and self efficacy theory. The hypotheses of this study are: 1) Participants in the intervention group will have higher level of self-management behaviour after intervention compared to participants in the control group; 2) Participants in the intervention group will have better diabetes knowledge after intervention compared to participants in the control group; 3) Participants in the intervention group will have higher level of self-efficacy after intervention compared to participants in the control group; 4) Participants in the intervention group will be less depressed after intervention compared to participants in the control group; 5) Participants in the intervention group will have better QOL after intervention compared to participants in the control group; 6) Participants in the intervention group will gain greater reduction in HbA1c after intervention compared to participants in the control group; 7) Participants in the intervention group will gain greater reduction in fasting blood glucose after intervention compared to participants in the control group; 8) Participants in the intervention group will gain greater reduction in BP after intervention compared to participants in the control group; 9) Participants in the intervention group will gain greater reduction in BMI after intervention compared to participants in the control group.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention group

Experimental

Nurse-led Integrative health and wellness programme

干预措施: Nurse-led Integrative health and wellness programme (Behavioral)

control group

No Intervention

usual diabetes care

结局指标

主要结局

Self-management

时间窗: Three months post-intervention (T2)

self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.

次要结局

未报告次要终点

研究者

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

YU Xingfeng

Graduate Assistant

Chinese University of Hong Kong

研究点 (4)

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