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

Study Overview
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Nurse-led Integrative health and wellness programme


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Nurse-led Integrative health and wellness programme | Behavioral: Nurse-led Integrative health and wellness programme<br>* 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.<br>|
| No Intervention: control group<br>usual diabetes care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |