Diabetes MellitusNCT03353376
Group Versus Individual Care in Diabetes Clinic
A study testing group care with Empowerment model in people with Diabetes Mellitus and Group Meetings, run by Rabin Medical Center.
Trial summary
In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Group Meetings
- What is being tested?
- group care with Empowerment model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2010to 2 Jan 2014
- 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
- Diagnosis of type 1 or type 2 diabetes
- Fluency in Hebrew
- Attendance at least for the second time at the diabetes clinic
- Follow up of at least one year by a general practitioner
- Willingness to participate in the study and to give informed consent.
Who cannot join
- Uncontrolled psychiatric diseases
- Active cancer
- Pregnancy
About this study
Official title: Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic
In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.
Read the detailed description
in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.
- Conditions
- Diabetes Mellitus, Group Meetings
- Being tested
- group care with Empowerment model
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group care with Empowerment modelBehavioural
Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment
| Study group | Role | What they receive |
|---|---|---|
| group care with empowerment model | Experimental | 4 group visits a year according to empowerment model in a tertiary diabetes clinic Receives: Behavioral: group care with Empowerment model |
| individual usual care | Active comparator | individual visits according to disponibility in the diabetes clinic and needs of the patients Receives: Behavioral: group care with Empowerment model |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in in Hba1c levels
Collection of data at start and after one year
Measured: one year from date of randomization
Secondary outcomes (3)
change in scores of diabetes specific questionnaire
Collection of data at start and end of study from electronic files
Measured: one year from date of randomization
change in BMI in kg/m2
Collection of data (weight in kg, height in meter) at start and end of study from electronic files
Measured: one year from date of randomization
change in non HDL Cholesterol
Collection of data at start and end of study from electronic files
Measured: one year from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start13 Sep 2010
- Primary completion2 Jan 2014
- Study completion2 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noa Naftali, MA, Study chair, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353376
- Sponsor's protocol ID
- JSMG-01
- Status last verified
- Oct 2017
- First submitted
- 2 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic
- ClinicalTrials.gov ID
- NCT03353376
- Acronym / sponsor ID
- JSMG-01
- Conditions
- Diabetes Mellitus, Group Meetings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 13 Sep 2010 (actual)
- Primary completion
- 2 Jan 2014 (actual)
- Study completion
- 2 Jan 2014 (actual)
- First posted
- 27 Nov 2017 (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.
In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.
Detailed description
in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group care with empowerment model | Experimental | Behavioral: group care with Empowerment model4 group visits a year according to empowerment model in a tertiary diabetes clinic |
| individual usual care | Active comparator | Behavioral: group care with Empowerment modelindividual visits according to disponibility in the diabetes clinic and needs of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 1 or type 2 diabetes
- Fluency in Hebrew
- Attendance at least for the second time at the diabetes clinic
- Follow up of at least one year by a general practitioner
- Willingness to participate in the study and to give informed consent.
Key exclusion criteria (3 listed)
- Uncontrolled psychiatric diseases
- Active cancer
- Pregnancy
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 care with Empowerment modelPatients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment | Behavioural | group care with empowerment model, individual usual care |
Primary outcome
change in in Hba1c levels
Time frame: one year from date of randomization
Collection of data at start and after one year
3 secondary outcomes
change in scores of diabetes specific questionnaire
Time frame: one year from date of randomization
change in BMI in kg/m2
Time frame: one year from date of randomization
change in non HDL Cholesterol
Time frame: one year from date of randomization
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 27 Nov 2017.
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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.
Noa Naftali, MA study chair
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing group care with Empowerment model in people with Diabetes Mellitus and Group Meetings, run by Rabin Medical Center.
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 5 inclusion and 3 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
change in in Hba1c levels (time frame: one year from date of randomization). 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 27 Nov 2017.