Type 2 DiabetesPMC-SEPNCT04092569
Effectiveness of Pre-medical Consultation Diabetes Self-care Education Programme on Glycemic Control in Type 2 Diabetes
A study testing Pre-medical consultation structured diabetes self-care education programme in people with Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pre-medical consultation structured diabetes self-care education programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Sep 2019to 31 Dec 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes, age above 18 years old, who are 'newly referred' (established as well as newly diagnosed of DM) to specialist out-patient clinic at Alice Ho Miu Ling Nethersole Hospital
- Suboptimal glycemic control of glycosylated haemoglobin, HbA1c >7%
- Chinese and literate, able to answer questionnaires
Who cannot join
- Inability to give informed consent.
- Poor glycemic control with glycosylated haemoglobin, HbA1c >12% and/or related complications will receive early medical appointment or require hospital admission.
- Having advanced diabetes related complications, e.g. diabetes kidney disease with glomerular filtration rate (eGFR) <30 mL/min/1.72m2
- Life threatening condition with reduced life expectancy such as patients with cancer at terminal stage.
- Those with active mental disorders and learning disability.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital
Tai Po, New Territories
Siu Wai Maggie LAU, MPhil
About this study
Official title: The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes
This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital.
Read the detailed description
Protocol Revised Date: 23 April 2019
Introduction Diabetes Mellitus (DM) is known as one of the major causes leading to cardiovascular diseases, stroke, diabetes kidney diseases, blindness or non-traumatic lower limb amputations. It is estimated that one in ten people to have diabetes and it has been projected that one in three adults will develop type 2 diabetes by 2050. Similarly, the prevalence of Type 2 Diabetes Mellitus (T2DM) in Hong Kong is estimated to be one in ten in adult population.
DM is a progressive metabolic disease and necessitates continuous medical care, diabetes self-management education and skills training to prevent or delay development of acute and chronic complications. Educating patients with diabetes in self blood glucose monitoring, healthy eating, regular physical activities, medication adherence, stress management and smoking cessation are important behavioral modifications required in diabetes self-care education. Besides providing education, diabetes nurses provide support and discuss with patients regarding their concerns and worries about diabetes and empower them to live their life positively with diabetes.
The Service Gap
Patients with diabetes with or without cardiovascular or renal comorbidities, are inevitably a burden to healthcare system. In Hong Kong and most other countries, if not all, patients are referred to specialist out-patient clinics (SOPC) for more advanced diabetes management from either general out-patient clinics (GOPC) or private practitioners (GP). Hence, these new case referrals from GOPC or GP are patients already have established DM on oral anti-diabetic drugs and/or insulin injections and with diabetes complications. Nevertheless, they have to wait for a long period of time, approximately one to two years before they could be seen at SOPC.
The role of a diabetes nurse is recognized as providing diabetes education, individualized care, self-care promotion, teaching physical skills and enhancing psychological support. However, majority of DM patients are being first seen at general medical clinics, and only a proportion of them will be referred by case medical practitioner to diabetes nurses for education. In other words, the role of the diabetes nurses is quite 'passive' and the basic education program may fail to cover all newly referred patients.
According to Hospital Authority (HA) report, the waiting time for stable case new case booking in medicine specialist out-patient clinics from October 1, 2017 to September 30, 2018 is the median 94 weeks (= 24 months = 2 years) to the longest 119 weeks (= 30 months = 2.5 years) for first time medical consultation at SOPC. Most of them are with suboptimal glycemic control and/or co-morbidities, such as retinopathy or renal impairment at time of referral made and necessitate earlier medical management. Burden of diabetes on public health care system in Hong Kong is alarming. The number of patients with diabetes increased over 9,000 (31.5%) in five years from 2010 to 2015, with around 200,000 admissions for diabetes-related complications, which accounts for 18% of all admissions and around one million SOPC visits, which accounts for 14% of all SOPC attendance.
Thus, the clinical triggers are:
- What is the impact of delivering pre-medical consultation nursing intervention or diabetes education to these newly referred patients with type 2 diabetes at SOPC?
- What are the effects of early nursing consultation and diabetes self-care education on glycemic control and self-care in patients with type 2 diabetes?
Hypothesis Pre-medical consultation structured diabetes self-care education programme can provide significantly greater improvements in glycemic control and self-care behaviors in adults with type 2 diabetes than usual care.
Objectives
- To evaluate the effectiveness of pre-medical consultation structured diabetes self-care education programme on glycemic control in adults with type 2 diabetes.
- To assess the effectiveness of pre-medical consultation structured diabetes self-care education programme on diabetes-specific self-care behaviors.
- To examine acceptability and usefulness of the intervention protocol by conducting a focus group interview on the intervention group.
Proposed evidence-based intervention protocol The findings of integrative review revealed positive effects of diabetes education in improving glycemic control and promoting self-care among adults with type 2 diabetes. An evidence-based protocol is developed based on these findings to generate a structured diabetes self-care education programme for newly referred patients before their first medical consultation at SOPC to improve glycemic control and enhance self-care in adults with type 2 diabetes in Hong Kong.
Study design This will be a randomized controlled trial to examine the effects and acceptability of a structured diabetes self-care education programme for type 2 diabetes patients as an intervention group (IG) versus a control group (CG) of usual care in a specialist out-patient clinic of a regional hospital.
- Conditions
- Type 2 Diabetes
- Being tested
- Pre-medical consultation structured diabetes self-care education programme
- Keywords
- Pre-medical Consultation self-care education, Glycemic control
- 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.
Pre-medical consultation structured diabetes self-care education programmeBehavioural
The findings of integrative review revealed positive effects of DSME in improving glycemic control and promoting self-care among people with type 2 diabetes.
An evidence-based protocol is developed based on these findings to generate a DSME program for newly referred patients to SOPCs and before their first medical consultation to improve glycemic control and enhance self-care of people with type 2 diabetes in Hong Kong. The investigator will ensure that this study is conducted in compliance with ICH-GCP and in compliance with the Declaration of Helsinki.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Pre-medical consultation structured diabetes self-care education programme Receives: Behavioral: Pre-medical consultation structured diabetes self-care education programme |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months
Blood HbA1c will be taken at baseline diabetes complication screening, week 24 for both IG and CG.
Measured: At baseline, week 24.
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months
Blood HbA1c will be taken at baseline diabetes complication screening week 36 for both IG and CG.
Measured: At baseline, week 36.
Secondary outcomes (2)
The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire
The Diabetes Management Self-Efficacy Scale Questionnaire (C-DMSES) is a 20-item scale that assesses diabetes self-care, including blood glucose monitoring, dietary adherence and physical activity adherence. Participants are asked to read each of the 20 items and rate on a 0-10 Likert scale. Higher scale scores indicate better self-care behavior. This scale has been validated and shown satisfactory reliability (r=0.86) in research.
Measured: At baseline, week 24 and week 36.
The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form
The Chinese version of the Diabetes Empowerment Scale Questionnaire (C-DES) is a 10-item scale and includes five subscales: overcoming barriers, achieving goals, coping, determining suitable methods and obtaining support. Participants are asked to rate each of the 10 items on a 0-5 Likert scale. Higher scale scores indicate better self-efficacy. This scale has been validated and shown satisfactory reliability (r=0.95) in study.
Measured: At baseline, week 24 and week 36.
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 start10 Sep 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients who are 'newly referred for advanced diabetes management' from general practitioners or general out-patient clinic to specialist out-patient clinic of Alice Ho Miu Ling Nethersole Hospital from 1/8/2019 to 31/12/2019 will be recruited. After signing written informed consent on day of diabetes complication screening, they will be randomized into CG (n=10 for pilot study; n=60 for main study) or IG (n=10 for pilot study; n=60 for main study) groups, using sealed envelope, opened by an independent staff, containing randomly generated computer codes for group assignment. All patients will undergo diabetes complication screening including examination of eye and feet, collection of blood and urine samples and filling in DM questionnaires at baseline, and HbA1c with diabetes self-care questionnaires at 24 weeks (for IG only) and 36 weeks.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAU Siu Wai Maggie, Chinese University of Hong Kong
- Investigators
- Siu Wai Maggie LAU, MPhil, Principal investigator, Chinese Univeristy of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092569
- Sponsor's protocol ID
- 2019.255
- Acronym
- PMC-SEP
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04092569
- Acronym / sponsor ID
- PMC-SEP / 2019.255
- Conditions
- Type 2 Diabetes
- Keywords
- Pre-medical Consultation self-care education, Glycemic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- 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.
This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital.
Detailed description
Protocol Revised Date: 23 April 2019
Introduction Diabetes Mellitus (DM) is known as one of the major causes leading to cardiovascular diseases, stroke, diabetes kidney diseases, blindness or non-traumatic lower limb amputations. It is estimated that one in ten people to have diabetes and it has been projected that one in three adults will develop type 2 diabetes by 2050. Similarly, the prevalence of Type 2 Diabetes Mellitus (T2DM) in Hong Kong is estimated to be one in ten in adult population.
DM is a progressive metabolic disease and necessitates continuous medical care, diabetes self-management education and skills training to prevent or delay development of acute and chronic complications. Educating patients with diabetes in self blood glucose monitoring, healthy eating, regular physical activities, medication adherence, stress management and smoking cessation are important behavioral modifications required in diabetes self-care education. Besides providing education, diabetes nurses provide support and discuss with patients regarding their concerns and worries about diabetes and empower them to live their life positively with diabetes.
The Service Gap
Patients with diabetes with or without cardiovascular or renal comorbidities, are inevitably a burden to healthcare system. In Hong Kong and most other countries, if not all, patients are referred to specialist out-patient clinics (SOPC) for more advanced diabetes management from either general out-patient clinics (GOPC) or private practitioners (GP). Hence, these new case referrals from GOPC or GP are patients already have established DM on oral anti-diabetic drugs and/or insulin injections and with diabetes complications. Nevertheless, they have to wait for a long period of time, approximately one to two years before they could be seen at SOPC.
The role of a diabetes nurse is recognized as providing diabetes education, individualized care, self-care promotion, teaching physical skills and enhancing psychological support. However, majority of DM patients are being first seen at general medical clinics, and only a proportion of them will be referred by case medical practitioner to diabetes nurses for education. In other words, the role of the diabetes nurses is quite 'passive' and the basic education program may fail to cover all newly referred patients.
According to Hospital Authority (HA) report, the waiting time for stable case new case booking in medicine specialist out-patient clinics from October 1, 2017 to September 30, 2018 is the median 94 weeks (= 24 months = 2 years) to the longest 119 weeks (= 30 months = 2.5 years) for first time medical consultation at SOPC. Most of them are with suboptimal glycemic control and/or co-morbidities, such as retinopathy or renal impairment at time of referral made and necessitate earlier medical management. Burden of diabetes on public health care system in Hong Kong is alarming. The number of patients with diabetes increased over 9,000 (31.5%) in five years from 2010 to 2015, with around 200,000 admissions for diabetes-related complications, which accounts for 18% of all admissions and around one million SOPC visits, which accounts for 14% of all SOPC attendance.
Thus, the clinical triggers are:
- What is the impact of delivering pre-medical consultation nursing intervention or diabetes education to these newly referred patients with type 2 diabetes at SOPC?
- What are the effects of early nursing consultation and diabetes self-care education on glycemic control and self-care in patients with type 2 diabetes?
Hypothesis Pre-medical consultation structured diabetes self-care education programme can provide significantly greater improvements in glycemic control and self-care behaviors in adults with type 2 diabetes than usual care.
Objectives
- To evaluate the effectiveness of pre-medical consultation structured diabetes self-care education programme on glycemic control in adults with type 2 diabetes.
- To assess the effectiveness of pre-medical consultation structured diabetes self-care education programme on diabetes-specific self-care behaviors.
- To examine acceptability and usefulness of the intervention protocol by conducting a focus group interview on the intervention group.
Proposed evidence-based intervention protocol The findings of integrative review revealed positive effects of diabetes education in improving glycemic control and promoting self-care among adults with type 2 diabetes. An evidence-based protocol is developed based on these findings to generate a structured diabetes self-care education programme for newly referred patients before their first medical consultation at SOPC to improve glycemic control and enhance self-care in adults with type 2 diabetes in Hong Kong.
Study design This will be a randomized controlled trial to examine the effects and acceptability of a structured diabetes self-care education programme for type 2 diabetes patients as an intervention group (IG) versus a control group (CG) of usual care in a specialist out-patient clinic of a regional hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients who are 'newly referred for advanced diabetes management' from general practitioners or general out-patient clinic to specialist out-patient clinic of Alice Ho Miu Ling Nethersole Hospital from 1/8/2019 to 31/12/2019 will be recruited. After signing written informed consent on day of diabetes complication screening, they will be randomized into CG (n=10 for pilot study; n=60 for main study) or IG (n=10 for pilot study; n=60 for main study) groups, using sealed envelope, opened by an independent staff, containing randomly generated computer codes for group assignment. All patients will undergo diabetes complication screening including examination of eye and feet, collection of blood and urine samples and filling in DM questionnaires at baseline, and HbA1c with diabetes self-care questionnaires at 24 weeks (for IG only) and 36 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Pre-medical consultation structured diabetes self-care education programmePre-medical consultation structured diabetes self-care education programme |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes, age above 18 years old, who are 'newly referred' (established as well as newly diagnosed of DM) to specialist out-patient clinic at Alice Ho Miu Ling Nethersole Hospital
- Suboptimal glycemic control of glycosylated haemoglobin, HbA1c >7%
- Chinese and literate, able to answer questionnaires
Key exclusion criteria (5 listed)
- Inability to give informed consent.
- Poor glycemic control with glycosylated haemoglobin, HbA1c >12% and/or related complications will receive early medical appointment or require hospital admission.
- Having advanced diabetes related complications, e.g. diabetes kidney disease with glomerular filtration rate (eGFR) <30 mL/min/1.72m2
- Life threatening condition with reduced life expectancy such as patients with cancer at terminal stage.
- Those with active mental disorders and learning disability.
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 |
|---|---|---|
| Pre-medical consultation structured diabetes self-care education programmeThe findings of integrative review revealed positive effects of DSME in improving glycemic control and promoting self-care among people with type 2 diabetes. An evidence-based protocol is developed based on these findings to generate a DSME program for newly referred patients to SOPCs and before their first medical consultation to improve glycemic control and enhance self-care of people with type 2 diabetes in Hong Kong. The investigator will ensure that this study is conducted in compliance with ICH-GCP and in compliance with the Declaration of Helsinki. | Behavioural | Intervention group |
Primary outcome
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months
Time frame: At baseline, week 24.
Blood HbA1c will be taken at baseline diabetes complication screening, week 24 for both IG and CG.
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 9 months
Time frame: At baseline, week 36.
Blood HbA1c will be taken at baseline diabetes complication screening week 36 for both IG and CG.
2 secondary outcomes
The Chinese version of the Diabetes Management Self-Efficacy Scale Questionnaire
Time frame: At baseline, week 24 and week 36.
The Chinese version of the Diabetes Empowerment Scale Questionnaire - Short Form
Time frame: At baseline, week 24 and week 36.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Siu Wai Maggie LAU, MPhil principal investigator
Chinese Univeristy 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 Pre-medical consultation structured diabetes self-care education programme 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siu Wai Maggie LAU, MPhil ((852) 91526018, 1092210290@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Blood Glycosylated haemoglobin, HbA1c at 6 months (time frame: At baseline, week 24.). The study lists 2 primary outcomes in all. 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 25 Sep 2019.