Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04092023
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2019-09-12
Brief Title:
Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effects of a Self-care Management Programme for Type 2 Adult Diabetic Patients With Poor Glycemic Control in General Out-patients Clinics - a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T2DM
Brief Summary:
Type 2 diabetes becomes the most prevalence chronic disease worldwide Most type 2 diabetes patient are under the care in public general out-patient clinic in Hong Kong The chronic nature of diabetic and the complexity of its management on top of medication diabetic patients often require behaviour modification and self-care management support Effective diabetes self-care management education with patient-centered care approach with patients participation and engagement has been shown to improve the clinical outcome But such application during doctors consultation are minimal in view of time limitation Primary Care Nurse PCN is the first contact and is easily accessible in GOPCs With support and training PCN could act as a case manager to deliver the coordinated care Interact and engage type 2 diabetes patients in self-care management and work with multidisciplinary team in providing patient-centered care in GOPC setting As there is lack of evidence about adopting such approach in the investigators local population This study is to test the effectiveness of the PCN led self-care management program to improve patients clinical outcomes
Detailed Description:
1 Safety Assessment
There is no harmful effect from the intervention
2 Statistics
A Sample Size Estimation With reference from previous study Aanand et al 2011 the sample size is calculated by assuming change the reduction of HbA1c is 059 intervention group 805 SD 140 versus control group 864 SD 139 In order to have 80 power and 5 false positive error a sample size of 88 is needed for each arm using the public domain sample size calculator httpswww2ccrbcuhkeduhkstat After consideration of 10 attrition rate 97 participants will be recruited in each arm
B Data Analysis All statistical analyses will be performed using SPSS Windows 220 program P-value less than 005 will be considered statistically significant All treatment evaluations will be performed on the principle of intention-to-treat analysis of the difference in outcomes between groups at 6 months after baseline Missing values will be imputed using last value carrying forward method Repeated analysis will be done for per-protocol analysis Demographics and baseline characteristics will be summarized using descriptive statistics Continuous variable will be summarized as numbers of observed values mean and standard deviation Categorical variables will be described as frequency and percentage Information collected on all outcomes will be first summarized using descriptive statistics at baseline and at 6 months as appropriate Linear regression model will be used to test the effect of intervention on the outcomes between 2 groups
3 Direct Access to Source Data and Documents
Apart from the outpatient number and Initials no subject sensitive identifier will be contained in the completed questionnaires All completed questionnaires will be kept in knocked administrative room in research site with limited access by investigators All patient records in CMS will be accessed by investigators only by their own CMS login
4 Quality Control and Quality Assurance
Expert panel including family medicine specialist diabetes nurse consultant diabetes nurse working in primary health care setting dietitian physiotherapist and podiatry will review the education contents Nurses who have received structural education on chronic disease management as organized by Institute of Advanced Nursing Studies Hospital Authority will be assigned to provide intervention to participants All the interventionist and co-investigator will be trained for 4 hours by principal investigator for the objectives contents and process of program before implementation Meeting will be held during the process of data collection to exchange ideas and knowledge between the interventionist
Principal investigator will monitor in all study phase The interaction between interventionists and participants will be guided by protocol and guideline Co-investigator in individual clinic will monitor participants recruitment and data collection Principal investigator will randomly check and sit in to monitor the consistency
5 Ethics and Data Handling
Ethics of this study will be complied with the Declaration of Helsinki Investigators will explain the study in detail and subjects will sign an informed consent form with written information sheet Investigators will clarify all the queries with subjects The enrolment will be entirely voluntary and it will not affect their care received in the study site All the personal identifiers will be removed during data processing The relevant documents will be kept in a locked cabinet in the study site and will be retained for 3 years after the study end
There is no harmful effect from the intervention
2 Statistics
A Sample Size Estimation With reference from previous study Aanand et al 2011 the sample size is calculated by assuming change the reduction of HbA1c is 059 intervention group 805 SD 140 versus control group 864 SD 139 In order to have 80 power and 5 false positive error a sample size of 88 is needed for each arm using the public domain sample size calculator httpswww2ccrbcuhkeduhkstat After consideration of 10 attrition rate 97 participants will be recruited in each arm
B Data Analysis All statistical analyses will be performed using SPSS Windows 220 program P-value less than 005 will be considered statistically significant All treatment evaluations will be performed on the principle of intention-to-treat analysis of the difference in outcomes between groups at 6 months after baseline Missing values will be imputed using last value carrying forward method Repeated analysis will be done for per-protocol analysis Demographics and baseline characteristics will be summarized using descriptive statistics Continuous variable will be summarized as numbers of observed values mean and standard deviation Categorical variables will be described as frequency and percentage Information collected on all outcomes will be first summarized using descriptive statistics at baseline and at 6 months as appropriate Linear regression model will be used to test the effect of intervention on the outcomes between 2 groups
3 Direct Access to Source Data and Documents
Apart from the outpatient number and Initials no subject sensitive identifier will be contained in the completed questionnaires All completed questionnaires will be kept in knocked administrative room in research site with limited access by investigators All patient records in CMS will be accessed by investigators only by their own CMS login
4 Quality Control and Quality Assurance
Expert panel including family medicine specialist diabetes nurse consultant diabetes nurse working in primary health care setting dietitian physiotherapist and podiatry will review the education contents Nurses who have received structural education on chronic disease management as organized by Institute of Advanced Nursing Studies Hospital Authority will be assigned to provide intervention to participants All the interventionist and co-investigator will be trained for 4 hours by principal investigator for the objectives contents and process of program before implementation Meeting will be held during the process of data collection to exchange ideas and knowledge between the interventionist
Principal investigator will monitor in all study phase The interaction between interventionists and participants will be guided by protocol and guideline Co-investigator in individual clinic will monitor participants recruitment and data collection Principal investigator will randomly check and sit in to monitor the consistency
5 Ethics and Data Handling
Ethics of this study will be complied with the Declaration of Helsinki Investigators will explain the study in detail and subjects will sign an informed consent form with written information sheet Investigators will clarify all the queries with subjects The enrolment will be entirely voluntary and it will not affect their care received in the study site All the personal identifiers will be removed during data processing The relevant documents will be kept in a locked cabinet in the study site and will be retained for 3 years after the study end
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None