Diabetes Mellitus, Type 2NCT06513468
The Value of Adding Group Education (DESMOND Method) to the Standard Primary Care Education Practices in Changing Glycemic Control and Self-care Practices in Adults With Type II Diabetes Mellitus: A Randomized Controlled Intervention Study.
A study testing Group education session by DESMOND Program in people with Diabetes Mellitus, Type 2, run by Primary Health Care Corporation, Qatar at 1 site in Qatar.
Trial summary
The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Group education session by DESMOND Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteQatar
- Study dates
- Oct 2024to Oct 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult more than 18 years, newly diagnosed Type II diabetes mellitus (within 4 - 6 weeks of diagnosis) attending the Airport Health Care Center.
- Not yet receiving any form of standard health education in PHCC.
Who cannot join
- Using diuretics or cancer therapy.
- Had enduring mental health problem.
- Participants in another research study.
- Inability to communicate in Arabic or English language
Trial locations and contacts
1 site in 1 country.
Qatar1 site
Primary Health Care Corporation
Doha, 26555
PHCC IRB, +974 4406 9917 ext. 40271109, researchsection@phcc.gov.qa
About this study
The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . The main questions it aims to answer is:
Does adding group education (DESMOND method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with Type II Diabetes Mellitus .
The enrolled study participants will be randomized to receive either the standard personal health care or group health education (DESMOND) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
Read the detailed description
- Objectives: This pilot, single primary healthcare center study is designed to assess the effect of delivering the group health education DESMOND program as an add-on to the standard health education in type 2 diabetic patients.
- Design: This is an analytic randomized controlled intervention study for adult patients who are newly diagnosed type II Diabetes Mellitus. The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session. A standard questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
- Setting :The Family Medicine clinics in Airport Health Center in Primary care, Qatar.
- Participants: Newly diagnosed type II Diabetes Mellitus aged more than 18 years.
- Intervention: A six-hour structured group education program to be delivered by one certified DESMOND health educator compared with the standard care.
- Main outcome measures : Blood HbA1C % at baseline (before starting the diabetes management protocol of PHCC), after 3, and 6 months of follow up. In addition, the Diabetes self-management score (DSMQ) after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Group education session by DESMOND Program
- Keywords
- Diabetes self management, DESMOND, effect of diabetes self management on 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.
Group education session by DESMOND ProgramOther
Also called The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed with Type II diabetes
is a validated structured education program for people with type 2 diabetes and their family members or carers (as appropriate)' This management approach was advised by the National Institute for Health and Care Excellence (NICE) in the UK since 2008. The program consists of a 6-hour face-to-face education session delivered by two trained educators over one day or two half-days to a group of 8-12 people with newly-diagnosed or ongoing type 2 diabetes. Annual reinforcement and review are part of the program , it is delivered as a business and usual in the secondary healthcare system of Qatar. The program is culturally adapted for Qatar considering beliefs and other health festivities.
| Study group | Role | What they receive |
|---|---|---|
| The standard health education of primary care . | Active comparator | The first group will receive a standard health education for self-care practices done by attending two appointments in our clinics with the health education and dietitian in a personal session. The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done. Receives: Other: Group education session by DESMOND Program |
| The standard group health education (DESMOND) session | Experimental | The second group will attend a group health education using a standard DESMOND method (10-12 patients for each session lasting for 6 hours over one day by certified DESMOND educator in the conference room of the health center). The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done. Receives: Other: Group education session by DESMOND Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood HbA1C %
before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
Measured: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
The Diabetes self-management score using the (DSMQ)
The Diabetes self-management score (DSMQ) at baseline , after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method
Measured: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primary Health Care Corporation, Qatar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Engy Salah Mohamed Abdelhamed, Primary Health Care Corporation, Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513468
- Sponsor's protocol ID
- PHCCQatar
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will keep participant name and other data confidential. it will be stored confidentially with the researcher only, and he may access to the data or specimens, for further research purpose in future.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Adding Group Education (DESMOND Method) to the Standard Primary Care Education Practices in Changing Glycemic Control and Self-care Practices in Adults With Type II Diabetes Mellitus: A Randomized Controlled Intervention Study.
- ClinicalTrials.gov ID
- NCT06513468
- Acronym / sponsor ID
- PHCCQatar
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes self management, DESMOND, effect of diabetes self management on glycemic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Primary Health Care Corporation, QatarOther government
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . The main questions it aims to answer is:
Does adding group education (DESMOND method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with Type II Diabetes Mellitus .
The enrolled study participants will be randomized to receive either the standard personal health care or group health education (DESMOND) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
Detailed description
- Objectives: This pilot, single primary healthcare center study is designed to assess the effect of delivering the group health education DESMOND program as an add-on to the standard health education in type 2 diabetic patients.
- Design: This is an analytic randomized controlled intervention study for adult patients who are newly diagnosed type II Diabetes Mellitus. The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session. A standard questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
- Setting :The Family Medicine clinics in Airport Health Center in Primary care, Qatar.
- Participants: Newly diagnosed type II Diabetes Mellitus aged more than 18 years.
- Intervention: A six-hour structured group education program to be delivered by one certified DESMOND health educator compared with the standard care.
- Main outcome measures : Blood HbA1C % at baseline (before starting the diabetes management protocol of PHCC), after 3, and 6 months of follow up. In addition, the Diabetes self-management score (DSMQ) after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session
| Arm | Type | Receives |
|---|---|---|
| The standard health education of primary care . | Active comparator | Other: Group education session by DESMOND ProgramThe first group will receive a standard health education for self-care practices done by attending two appointments in our clinics with the health education and dietitian in a personal session. The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done. |
| The standard group health education (DESMOND) session | Experimental | Other: Group education session by DESMOND ProgramThe second group will attend a group health education using a standard DESMOND method (10-12 patients for each session lasting for 6 hours over one day by certified DESMOND educator in the conference room of the health center). The HA1C blood test together with completing a brief questionnaire form measuring the Diabetes Self-Care Activities during the past three months will be done after 3 and, 6 months will be done. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult more than 18 years, newly diagnosed Type II diabetes mellitus (within 4 - 6 weeks of diagnosis) attending the Airport Health Care Center.
- Not yet receiving any form of standard health education in PHCC.
Key exclusion criteria (4 listed)
- Using diuretics or cancer therapy.
- Had enduring mental health problem.
- Participants in another research study.
- Inability to communicate in Arabic or English language
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 |
|---|---|---|
| Group education session by DESMOND ProgramAlso: The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed with Type II diabetesis a validated structured education program for people with type 2 diabetes and their family members or carers (as appropriate)' This management approach was advised by the National Institute for Health and Care Excellence (NICE) in the UK since 2008. The program consists of a 6-hour face-to-face education session delivered by two trained educators over one day or two half-days to a group of 8-12 people with newly-diagnosed or ongoing type 2 diabetes. Annual reinforcement and review are part of the program , it is delivered as a business and usual in the secondary healthcare system of Qatar. The program is culturally adapted for Qatar considering beliefs and other health festivities. | Other | The standard group health education (DESMOND) session, The standard health education of primary care . |
Primary outcome
Blood HbA1C %
Time frame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
The Diabetes self-management score using the (DSMQ)
Time frame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms
The Diabetes self-management score (DSMQ) at baseline , after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No. we will keep participant name and other data confidential. it will be stored confidentially with the researcher only, and he may access to the data or specimens, for further research purpose in future.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group education session by DESMOND Program in people with Diabetes Mellitus, Type 2, run by Primary Health Care Corporation, Qatar at 1 site in Qatar.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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 Qatar. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood HbA1C % (time frame: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms). 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 22 Jul 2024.