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Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients (NIHaW)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nurse-led Integrative health and wellness programme
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • individuals with a terminal illness
  • individuals who were physically disabled
  • individuals who were taking part in other studies
  • individuals with aural or visual problems

Sites / Locations

  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • The Shaanxi Provincial People's Hospital
  • Xi'an Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

Nurse-led Integrative health and wellness programme

usual diabetes care

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2017
Last Updated
July 18, 2018
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03261895
Brief Title
Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients
Acronym
NIHaW
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Nurse-led Integrative health and wellness programme
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual diabetes care
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led Integrative health and wellness programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-management
Description
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.
Time Frame
Baseline (T0)
Title
Self-management
Description
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.
Time Frame
Immediately post-intervention (T1)
Title
Self-management
Description
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.
Time Frame
Three months post-intervention (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: individuals with a terminal illness individuals who were physically disabled individuals who were taking part in other studies individuals with aural or visual problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingfeng YU
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
The Shaanxi Provincial People's Hospital
City
Xi'an
Country
China
Facility Name
Xi'an Central Hospital
City
Xi'an
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35932073
Citation
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.
Results Reference
derived

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Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients

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