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

NCT ID: NCT03261895

Last Updated: 2018-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

Nurse-led Integrative health and wellness programme

Group Type EXPERIMENTAL

Nurse-led Integrative health and wellness programme

Intervention Type BEHAVIORAL

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.

control group

usual diabetes care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nurse-led Integrative health and wellness programme

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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YU Xingfeng

Graduate Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xingfeng YU

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

The Shaanxi Provincial People's Hospital

Xi'an, , China

Site Status

Xi'an Central Hospital

Xi'an, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35932073 (View on PubMed)

Other Identifiers

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NIHaW

Identifier Type: -

Identifier Source: org_study_id

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