Plain English Summary
Background and study aims
Diabetes is a serious chronic disease that affects people worldwide and it is the fifth leading cause of death in Taiwan. Since the size of the aging population is growing, the prevalence of diabetes continues to rise, so the disease is likely to continue to cause medical and economic burdens within Taiwan. In recent decades, health and wellness coaching has become a new technique used in the care and management of chronic diseases around the world. So far, health behavior counseling become more and more important in chronic diseases management. But until now, there are almost no behavior consultant service within hospitals in Taiwan. The aim of this study is to find out whether a health coaching intervention could improve type 2 diabetes patients' HbA1c control, self-management efficacy and health behaviors.
Who can participate?
Patients aged 20 to 75 who have had type 2 diabetes for at least one year and an HbA1c of 7.0% or higher in the last 6 months
What does the study involve?
Participants selected the group they wished to join: either a health coaching intervention every two weeks or a health coaching intervention only when they returned for a check-up every 3 months. The coach helps them to set their own HbA1c and behaviour goal. Once they set their 6-month goal, they have to set their action plan and the coach tracks their work in the following six sessions. The coach has International Coach Federation ACC credentials. Both groups have general diabetes education. HbA1c (a measure of how well a person's diabetes is being controlled) is measured by blood test at the start of the study, 3 months, 6 months and 1 year.
What are the possible benefits and risks of participating?
There will be no assured direct benefits to those taking part since it depends on the degree of effort that participants put in. There are no risks of health coaching since both groups have diabetes health education before the intervention. Also, participants can call two certified diabetes educators at any time.
Where is the study run from?
Cathay General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
June 2017 to October 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Ching-Ling Lin
work5halfday@cgh.org.tw
2. Associate Professor Ruey-Yu Chen
rueyyu@tmu.edu.tw
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ching-Ling Lin
ORCID ID
http://orcid.org/0000-0002-9548-6300
Contact details
Department of Endocrinology & Metabolism
Cathay General Hospital
280 Renai Rd. Sec.4
Taipei
106
Taiwan
+886 (0)2 27082121 # 3165
work5halfday@cgh.org.tw
Type
Scientific
Additional contact
Prof Ruey-Yu Chen
ORCID ID
Contact details
School of Public Health
Taipei Medical University
No.250
Wu-Hsing Street
Taipei
110
Taiwan
+886 (0)2 27361661 #6521
rueyyu@tmu.edu.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An innovative approach for increasing adherence to medical regiment and glycaemic control among type II diabetes patients: a randomized controlled trial of hospital-based health coaching
Acronym
Study hypothesis
Health coaching intervention could improve type 2 diabetes patients' HbA1c control, self-management efficacy and health behaviors.
Ethics approval
Cathay General Hospital, 05/06/2017, ref: CGH-OP106001
Study design
Single-centre two-arm non-blinded interventional quasi-experimental design
Primary study design
Interventional
Secondary study design
Quasi-experimental design
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Participants were recruited from Cathay General Hospital in Taipei, Taiwan. Two physicians who specialize in endocrine and metabolic disorders screened potential patients with type 2 diabetes mellitus. If a patient met the inclusion criteria, one of the doctors explained the study and assessed his or her willing to participate. Once they agree to join and sign informed consent, participants selected the group they wished to join: (1) coaching intervention every two weeks or (2) coaching intervention only when they returned for a check-up every three months. The study design was not blinded. The health coaching intervention includes one face-to-face coaching session at start and six sessions telephone coaching within six months. Coachees have to set their HbA1c goal and their behavior change goal, then follow up by coach. The coach has International Coach Federation ACC credentials. Both groups have general diabetes education. Data collection to evaluate outcomes difference between baseline and upon completion of the every 3 months within study period.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
HbA1c (%), measured by biochemical test at baseline, 3 months, 6 months and 1 year
Secondary outcome measures
Measured at baseline, 3 months, 6 months and 1 year:
1. Self-management efficacy, measured using Perceived Diabetes Self-Management Scale
2. Physical activity, measured using Godin leisure-time physical activity scale
3. Self-blood glucose monitoring, measured using self-report
Overall trial start date
05/06/2017
Overall trial end date
31/10/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with type 2 diabetes for at least one year
2. 20 to 75 years old
3. HbA1c of 7.0% or greater in the last six months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Total final enrolment
116
Participant exclusion criteria
1. Type 1 diabetes mellitus
2. Pregnant or trying to become pregnant
3. Participated in another similar program in the last 6 months
4. Clinically significant depression or cognitive dysfunction
5. Failed to sign informed consent
Recruitment start date
05/06/2017
Recruitment end date
31/10/2017
Locations
Countries of recruitment
Taiwan
Trial participating centre
Cathay General Hospital
280 Renai Rd. Sec.4
Taipei
106
Taiwan
Sponsor information
Organisation
Cathay General Hospital
Sponsor details
280 Renai Rd. Sec.4
Taipei
106
Taiwan
+886 (0)2 27082121
work5haveday@cgh.org.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in Diabetes Care
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Yao-Tsung Chang, who can provide clean SPSS data (.sav). This data will become available once the paper has been published. This data will be completely anonymous, meets the IRB approval requirement, and all variables' definitions will be marked in the .sav data.
Intention to publish date
09/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31737593 (added 19/11/2019)