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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Siu Wai Maggie LAU, MPhil contact

(852) 91526018

1092210290@link.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Diabetes Centre, Alice Ho Miu Ling Nethersole Hospital

    Tai Po, New Territories

    Siu Wai Maggie LAU, MPhil

    Recruiting

Other trials in Hong Kong

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:

  1. 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?
  2. 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

  1. To evaluate the effectiveness of pre-medical consultation structured diabetes self-care education programme on glycemic control in adults with type 2 diabetes.
  2. To assess the effectiveness of pre-medical consultation structured diabetes self-care education programme on diabetes-specific self-care behaviors.
  3. 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 groups in NCT04092569
Study groupRoleWhat they receive
Intervention groupActive comparatorPre-medical consultation structured diabetes self-care education programme
Receives: Behavioral: Pre-medical consultation structured diabetes self-care education programme
Control groupNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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)
  1. 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.

  2. 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.

  1. First posted17 Sep 2019
  2. Study start10 Sep 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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)
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

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.

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