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Clinical Trials/NCT03261895
NCT03261895
Completed
N/A

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 sites in 1 country128 target enrollmentMay 4, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Chinese University of Hong Kong
Enrollment
128
Locations
4
Primary Endpoint
Self-management
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2017
End Date
December 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

YU Xingfeng

Graduate Assistant

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Self-management

Time Frame: 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.

Study Sites (4)

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