Type 2 DiabetesT2DMNCT04092023
Self-care Management Programme for Type 2 Adult DM Patients With Poor Glycemic Control
A study testing nursing education in people with Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- nursing education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >=18
- Clinically diagnosed of type 2 diabetes
- Poorly glycemic control with recent HbA1c ≧ 7.5%
- Chinese participants who could speak Cantonese
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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 investigator's local population. This study is to test the effectiveness of the PCN led self-care management program to improve patients' clinical outcomes.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- nursing education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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. Receives: Other: nursing education |
| Intervention group | Other | 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. Receives: Other: nursing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Blood test for HbA1c
Measured: Assess change from Baseline HbA1c at 6 months
Secondary outcomes (3)
Diabetes Knowledge
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.
Measured: Assess change from Baseline HbA1c at 6 months
Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)
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.
Measured: Assess change from Baseline HbA1c at 6 months
QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)
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.
Measured: Assess change from Baseline HbA1c at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start2 Oct 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A six month and two-arm parallel randomized control trial is employed
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Ching Yee, Chinese University of Hong Kong
- Investigators
- Ching Y Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092023
- Sponsor's protocol ID
- ChanCY_RP1
- Acronym
- T2DM
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04092023
- Acronym / sponsor ID
- T2DM / ChanCY_RP1
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 investigator's local population. This study is to test the effectiveness of the PCN led self-care management program to improve patients' clinical outcomes.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A six month and two-arm parallel randomized control trial is employed
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: nursing educationParticipants 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. |
| Intervention group | Other | Other: nursing educationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >=18
- Clinically diagnosed of type 2 diabetes
- Poorly glycemic control with recent HbA1c ≧ 7.5%
- Chinese participants who could speak Cantonese
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nursing educationParticipants 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. | Other | Control group, Intervention group |
Primary outcome
Glycemic control
Time frame: Assess change from Baseline HbA1c at 6 months
Blood test for HbA1c
3 secondary outcomes
Diabetes Knowledge
Time frame: Assess change from Baseline HbA1c at 6 months
Self-Efficacy: Diabetes Empowerment Scale - Short Form (C-DES-SF)
Time frame: Assess change from Baseline HbA1c at 6 months
QOL: Audit of Diabetes Dependent Quality of Life (ADDQoL-19)
Time frame: Assess change from Baseline HbA1c at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching Y Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing education in people with Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Assess change from Baseline HbA1c at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.