Clinical trial NCT03261895: Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Self-management
timeFrame: Baseline (T0)
measure: Self-management
timeFrame: Immediately post-intervention (T1)
measure: Self-management
timeFrame: Three months post-intervention (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xi'an
country: China
facility: The Shaanxi Provincial People's Hospital
city: Xi'an
country: China
facility: Xi'an Central Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Xingfeng YU
role: PRINCIPAL_INVESTIGATOR
References:
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.