- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092023
Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control (T2DM)
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
Study Overview
Detailed Description
Safety Assessment
There is no harmful effect from the intervention.
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 0.59% (intervention group 8.05% (SD 1.40) versus control group 8.64% (SD 1.39). 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 (https://www2.ccrb.cuhk.edu.hk/stat/). 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 22.0 program. P-value less than 0.05 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.
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.
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.
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- KWC FM & PHC, Hospital Authority
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged >=18
- Clinically diagnosed of type 2 diabetes
- Poorly glycemic control with recent HbA1c ≧ 7.5%
- Chinese participants who could speak Cantonese
Exclusion Criteria:
- Unable to perform self-care management due to physical or mental limitation
- Engage in another similar program
- Pregnancy
- Life expectancy <1 year due to malignancies or other terminal illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
Participants in control group will be received usual care.
They will be gone through yearly DM complication screening.
A screening report and information sheet on general DM management will be issued to participants.
Therapeutic goals will be set and further conventional health care education intervention will be referred.
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Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes.
Two subsequent phones follow up to participants will be arranged.
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Other: Intervention group
The interventions are designed to address the seven key self-management behaviours identified by the Association of American Diabetes Educations: (1) healthy eating, (2) being active, (3) monitoring, (4) taking medication, (5) problem solving, (6) reducing risk, and (7) healthy coping.
In addition, the Chronic Care Model elements of self-management support and patient centered-care approach is embraced during the intervention process.
The nursing care components provided to participants will be included (a) self-care management knowledge, (b) skill-based learning and problem solving, (c) participants' participation and engagement, (d) participants' in goal setting, and (e) coordinate care, involve participants to make decision.
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Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes.
Two subsequent phones follow up to participants will be arranged.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic control
Time Frame: Assess change from Baseline HbA1c at 6 months
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Blood test for HbA1c
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Assess change from Baseline HbA1c at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes Knowledge
Time Frame: Assess change from Baseline HbA1c at 6 months
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The Diabetes Knowledge Scale (DKN) (Dunn et al, 1984) will be adopted to measure participants' knowledge level.
The DKN questionnaire consists 15 multiple-choice items each related to test the participants' knowledge level on the major areas of basic physiology of diabetes and general principles of diabetes care.
A score of 1 is assigned for a correct response and 0 for an incorrect response.
The total score is calculated by summing the scores from 15 items.
The total scores are then converted to percentages.
High scores on this measure indicated a higher level of diabetes knowledge.
The original English version of the DKN questionnaire was translated into Chinese version by Chan & Molassiots (1999) and has been validated for Hong Kong Chinese T2DM patient in an out-patient diabetes clinic.
The content validity index is 0.96.
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Assess change from Baseline HbA1c at 6 months
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Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)
Time Frame: Assess change from Baseline HbA1c at 6 months
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Diabetes Empowerment Scale - Short Form (C-DES-SF) will be adopted to measure participants' self-efficacy level.
It has been validated for Hong Kong Chinese patient by Shiu, Choi & Wong (2012).
The Internal consistency (α = 0.77) and the test-retest validity (ICC 0.89, 95% CI 0.86-0.92).
The scale consists of 10 items and reports in a 5-points Likert scale.
An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 points.
An overall score for the C-DES-SF would be calculated by adding all of the item points.
Higher points represent higher level of self-efficacy to manage diabetes in his/her daily live.The items to be reported are (a) overcoming barriers, (b) determining suitable methods, (c) achieving goals, (e) obtaining support, and (f) coping.
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Assess change from Baseline HbA1c at 6 months
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QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)
Time Frame: Assess change from Baseline HbA1c at 6 months
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Audit of Diabetes Dependent Quality of Life (ADDQoL-19) will be used to measure participants' QOL.
The Internal consistency (α = 0.81) and the construct validity was proven (Fung & Wong, 2016).
The scale consists of 19 diabetes-specific domain items and reports in a 7-points scale.
Respondents rate the impact of diabetes on applicable domains on a scale from -3 (maxmium negative impact) to +1 (maximum postive impact).
Respondents then rate the importance of those domains for their QOL on a scale from 3 (very important) to 0 (not at all important).
Impact ratings are multiplied by the corresponding importance rating to provide a weighted-impact score for each domain from -9 (maximum ngeative impact) to +3 (maximum postive impact).
Weighted impact score are summed and divided by the number of applicable domains, to give a overall Average Weighted Impact (AWI) score.
Higher AWI scores represent a worse of quality of life as impacted by diabetes.
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Assess change from Baseline HbA1c at 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ching Y Chan, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ChanCY_RP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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