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Trial registered on ANZCTR


Registration number
ACTRN12618001741279
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
23/10/2018
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Jiangsu Province Center for Disease control-Hospital-Community integration comprehensive management program to patients with type 2 diabetes
Scientific title
Efficacy of integrated intervention program to reduce glycemic level and improve health outcomes in patients with type 2 diabetes
Secondary ID [1] 296205 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 309842 0
Condition category
Condition code
Metabolic and Endocrine 308632 308632 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten diabetes intervention sessions including scheduled glucose monitoring, diabetes specific nutritional plan, and group diabetes education are designed for this study. The number of sessions that participants attend is determined based on the pilot study we completed in 2017-2018. It was evident the intervention was effective if participants can attend at least 8 sessions. If participants skipped sessions, the local physicians will catch up the participants by phone or sending session materials to participants so they can catch up with the activity contents. These participants will be given opportunities to participate in activities to review their understanding of the intervention content. All intervention group participants will be provided diabetes intervention materials used for weekly group activities led by experienced community based physicians. The diabetes intervention materials are specially designed for this study. Each group consisted of 10-15 patients for 1 to 1.5 hours activities. The information included the following topics: thoughts and beliefs in diabetes management, diabetes self care behavious, behavioral and lifestyle modification including quitting smoking and drinking, physical activity, and knowledge of diabetes education, diabetes self care skills, healthy eating instruction and low glycemic foods based on Chinese Health Diet plan. In the education and information sessions, participants will attend workshop, learn the content through demonstrations, to conduct role plays and group discussion, Participants will attend weekly group sessions at their respective communities. For each session, it lasted 60 to 90 minutes, participants met with a community physician for diet consultations and medical evaluation in the same session. This includes review of behavioural modifications actions, assessment of blood glucose measurements and adjustment of medications. The integrative health care model will be developed by integrating Disease Control Center as project management, tertiary hospital to provide guidance and training and community doctors to do monitoring and management.
We are also trialing the online monitoring the patients weight control by using E-health method. This measure participants body weight, BMI, fat, bone and muscle strength, and metabolism process. Participants will measure their weights every week six months. The APP developed for the intervention will receive patients data and provide patients guidance after they send data through telecommunication method.
Intervention code [1] 312533 0
Treatment: Other
Intervention code [2] 312534 0
Behaviour
Intervention code [3] 312535 0
Lifestyle
Comparator / control treatment
The control group participants will only attend education session, The education session will be 2 hours workshop session including education content relating healthy diet, exercise, and medication adherence. Subsequently the control group participants will receive usual care by attending to regular health check and doctor visits.
Control group
Active

Outcomes
Primary outcome [1] 307593 0
Fasting blood glucose will be collected at all three time points.

Timepoint [1] 307593 0
Data collection will be conducted at baseline, midpoint (26 week) and endpoint (52 week), and the primary timepoint is 26 weeks.
Primary outcome [2] 307799 0
HbA1c will be collected. A blood sample is obtained by inserting a needle into a vein in the arm and the level of HbA1c will be assessed using laboratory technique by pathologists at hospital in Jiangsu Province. A procedure known as high
pressure (or performance) liquid chromatography (HPLC) will be used in the laboratory test. This test can separates mixtures (for example, blood) into its various
components by adding the mixtures to special liquids and passing
them under pressure through columns filled with a material that
separates the mixture into its different component molecules. The HbA1c content is
measured which is based on the ratio of HbA1c peak area to the
total hemoglobin peak areas.
Timepoint [2] 307799 0
Data collection will be conducted at baseline, midpoint (26 week) and endpoint (52 week), and the primary timepoint is 26 weeks.
Secondary outcome [1] 352379 0
Information on anthropometry data (including weight, BMI, fat level, muscle and bone density) will be collected using a electronic body scale.
Timepoint [1] 352379 0
Data collection will be conducted at baseline, midpoint (26 week) and endpoint (52 week)
Secondary outcome [2] 352982 0
Dietary intake will be collected using a questionnaire developed for this study
Timepoint [2] 352982 0
The data will be collected at baseline, 26 weeks and 52 weeks time.
Secondary outcome [3] 352983 0
Physical activity including vigorous level, moderate level, and mild activity level will be collected. This will be collected using both questionnaire and accelerometer. The physical activity questionnaire is designed for this study.
Timepoint [3] 352983 0
The data will be collected as baseline, midpoint (26 weeks), and end point (52 weeks) time
Secondary outcome [4] 352984 0
Medical history including chronic disease conditions (hypertension, cardiovascular disease, diabetes, and other chronic conditions) will be collected using patient-reported method. The questionnaire is designed for this study and data will be collected using this questionnaire.
Timepoint [4] 352984 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks) time.
Secondary outcome [5] 352985 0
Health knowledge on understanding the cause of diabetes, self-care knowledge of diabetes, and behavioural change and medication adherence will be measured by likert scale based questionnaire. This is a composite secondary outcome.
Timepoint [5] 352985 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks) time
Secondary outcome [6] 352986 0
Cognitive perception about diabetes will be assessed using questionnaire method. These questions are designed specifically for this study.
Timepoint [6] 352986 0
Data will be collected at baseline, mid point (26 weeks), and end points (52 weeks)
Secondary outcome [7] 352987 0
Self-care behavioural skills will be assessed using questionnaire which is specifically designed for this study.
Timepoint [7] 352987 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks).
Secondary outcome [8] 352991 0
Quality of life using SF-12 measure will be used.
Timepoint [8] 352991 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks).
Secondary outcome [9] 352992 0
Medication adherence for the diabetes control will be measured by questionnaire which is specifically designed for this study.
Timepoint [9] 352992 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks).
Secondary outcome [10] 352994 0
Mental health status including depression and anxiety will be measured using standard measure for screening. Beck Depression and Anxiety questionnaire will be used to assess patient depression and anxiety.
Timepoint [10] 352994 0
Data will be collected at baseline, midpoint (26 weeks), and end point (52 weeks).

Eligibility
Key inclusion criteria
All participants will need to provide written informed consent before being enrolled into the study. Inclusion criteria include men and women 18-80 years of age, diagnosed with T2DM.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they are pregnant, taking medications, had advanced diabetes complications, taking insulin, or had a recent history of a cardiovascular event, cancer, or other chronic disease that might interfere with participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After patients provide consent, they will be randomised into either intervention or control group according to the stratification of age and gender in each district. The allocation concealment process will be used and participants will not know which group they will be allocated to. The third party people will come to help with the allocation of participants with concealment. Experts with experience in RCT study will be invited to do the allocation and they will not be aware of the patients status and they will randomely allocate patients to the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence and numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat method will be used to analyse the data,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2018
Actual
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 20877 0
China
State/province [1] 20877 0
Jiangsu Province

Funding & Sponsors
Funding source category [1] 300789 0
Government body
Name [1] 300789 0
Bureau of Health
Country [1] 300789 0
China
Primary sponsor type
Individual
Name
Jing Sun
Address
School of Medicine, Griffith University, Parkland Drive, Gold Coast Queensland, Q4222, Australia
Country
Australia
Secondary sponsor category [1] 300346 0
None
Name [1] 300346 0
Address [1] 300346 0
Country [1] 300346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301573 0
Jiangsu Provincial Centre for Disease Prevention and Control
Ethics committee address [1] 301573 0
Ethics committee country [1] 301573 0
China
Date submitted for ethics approval [1] 301573 0
04/09/2018
Approval date [1] 301573 0
13/09/2018
Ethics approval number [1] 301573 0
AF/SC/LS08-V03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87430 0
Prof Yongqing Zhang
Address 87430 0
Jiangsu Provincial Center for Disease Prevention and Control, Jiangsu Province
172 Jiangsu Road, Nanjing, China 210009
Country 87430 0
China
Phone 87430 0
+86 13675163939
Fax 87430 0
86-25-83759469
Email 87430 0
[email protected]
Contact person for public queries
Name 87431 0
Jing Sun
Address 87431 0
School of Medicine, Griffith University, Queensland, Australia
Parkland Drive, Q4222
Country 87431 0
Australia
Phone 87431 0
+617 56780924
Fax 87431 0
+61756780303
Email 87431 0
[email protected]
Contact person for scientific queries
Name 87432 0
Jing Sun
Address 87432 0
School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland, Australia Q4222
Country 87432 0
Australia
Phone 87432 0
+617 56780924
Fax 87432 0
+61756780303
Email 87432 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.