Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients
NIHaW
1 other identifier
interventional
128
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started May 2017
Shorter than P25 for not_applicable diabetes-mellitus-type-2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJuly 20, 2018
July 1, 2018
8 months
August 21, 2017
July 18, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Self-management
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.
Baseline (T0)
Self-management
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.
Immediately post-intervention (T1)
Self-management
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.
Three months post-intervention (T2)
Study Arms (2)
Intervention group
EXPERIMENTALNurse-led Integrative health and wellness programme
control group
NO INTERVENTIONusual diabetes care
Interventions
Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.
Eligibility Criteria
You may qualify if:
- individuals diagnosed with type 2 diabetes in the preceding six months
- individuals aged ≥ 18 years
- individuals who were permanent residents of Xi'an City, China
- individuals without mental disorders
- individuals who were voluntary to participate in the study
You may not qualify if:
- individuals with a terminal illness
- individuals who were physically disabled
- individuals who were taking part in other studies
- individuals with aural or visual problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The Shaanxi Provincial People's Hospital
Xi'an, China
Xi'an Central Hospital
Xi'an, China
Related Publications (1)
Yu X, Chau JPC, Huo L, Li X, Wang D, Wu H, Zhang Y. The effects of a nurse-led integrative medicine-based structured education program on self-management behaviors among individuals with newly diagnosed type 2 diabetes: a randomized controlled trial. BMC Nurs. 2022 Aug 5;21(1):217. doi: 10.1186/s12912-022-00970-7.
PMID: 35932073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingfeng YU
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Assistant
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 25, 2017
Study Start
May 4, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
July 20, 2018
Record last verified: 2018-07