Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

NCT ID: NCT06184815

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-11-30

Brief Summary

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This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.

Detailed Description

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Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.

Conditions

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Type 1 Diabetes

Keywords

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type 1 diabetes Autoimmune Diseases Diabetes Education Programme DSMES Diabetes self-management education and support T1D Insulin-dependent diabetes Juvenile diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The standard educational and treatment program consists of outpatient management and education in the office and consultation referral to nutrition and psychology with a duration of 4 months.

Study Groups

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Educational programme 12

The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.

Group Type EXPERIMENTAL

Educational programme 12

Intervention Type BEHAVIORAL

Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment

Standard

The standard educational program consists of outpatient management with diabetic education slides and material for the patient, with a duration of 4 months. Standard treatment consists of endocrinology consultation with nutrition and psychology referral if required

Group Type ACTIVE_COMPARATOR

Standard education and treatment

Intervention Type BEHAVIORAL

Outpatient management and education in the office and consultation referral to nutrition and psychology

Interventions

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Educational programme 12

Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment

Intervention Type BEHAVIORAL

Standard education and treatment

Outpatient management and education in the office and consultation referral to nutrition and psychology

Intervention Type BEHAVIORAL

Other Intervention Names

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Standard

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* Diabetes duration \>1 year
* BMI 18.5-40kg/m2
* A1c 6.5-13%

Exclusion Criteria

* Pregnancy
* Dementia or severe cognitive impairment
* Uncontrolled psychiatric disorder
* Absence of \>20% of the educational sessions
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Sanchez Garcia

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico

Central Contacts

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David Sanchez, MD

Role: CONTACT

Phone: 8183714100

Email: [email protected]

Other Identifiers

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IMSST1D

Identifier Type: -

Identifier Source: org_study_id