Validation of an Integrated Attention Model for Patients With Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

Abstract: Empowerment interventions for chronic diseases are an evolving process. No agreement exists regarding the necessary components and methodologies to be applied. Systematic reviews have assessed the effect of self-management interventions. Improvements in illness beliefs, adherence to drug therapy and glucose monitoring have been reported. In the long term, no major changes have been achieved in weight, physical activity, smoking status, and depression scores.

There is a need for additional studies. The Center for Comprehensive Care of Patients with Diabetes (CAIPaDi) program is an intervention designed to provide education and empowerment techniques (using simple low-cost interactive tools) over a short period of time followed by at-distance support using internet or cell phone technology. The target population consists of patients with type 2 diabetes, free of chronic complications who are non-smokers. The intervention is composed of four monthly visits followed by a continuous at-distance support system. At each visit, patients stay for six hours in the center. Information is presented in group sessions. Empowerment techniques are applied during individual exchanges with the team or during facilitated group sessions. In summary, empowerment programs are an unmet need in many healthcare services.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

being over 18 and under 70 years old

having diagnosis of type 2 diabetes in the five previous years,

having family support

free of disabling diabetes complications

Disqualifiers

advanced complications of diabetes, such as ischemic heart disease, heart failure NYHA III-IV, KDOQI ≥3 renal failure, amputations, cerebral vascular disease, gastroparesis and muscular atrophy .

type 1 diabetes mellitus, gestational diabetes or some variant of diabetes related to genetic syndromes, hyperlabile diabetes

co-morbidities that limit their life expectancy such as malignant tumors

advanced cognitive impairment or serious psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAIPaDi

    Behavioral

    Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, dentists, psychiatrist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: CAIPaDiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diabetes control after 4 visits in a structured multidisciplinary program for patients with diabetes

HbA1c is measured in percentage (%). HbA1c will be compared from the first visit with the fourth visit.

Time frame
3 months

Secondary outcomes

1

Diabetes control after 1 year in a structured multidisciplinary program for patients with diabetes

HbA1c is measured in percentage (%). HbA1c will be compared from the fourth visit with the visit 1 year apart.

Time frame
1 year
2

Metabolic parameters are lipid profile after 1 year in a structured multidisciplinary program for patients with diabetes

Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. All of them will be compared from the fourth visit with the visit 1 year apart.

Time frame
1 year
3

Renal function after 1 year in a structured multidisciplinary program for patients with diabetes

Renal function in mg/g (albumin/creatinine ratio). Renal function will be compared from the fourth visit with the visit 1 year apart.

Time frame
1 year
4

Self-care by SDSCA questionnaire after 1 year in a structured multidisciplinary program for patients with diabetes

Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. This will be compared from the fourth visit with the visit 1 year apart.

Time frame
1 year

Other outcomes

1

Glucose control of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ.

HbA1c is measured in percentage (%). Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

Time frame
2 years
2

Lipid parameters of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ.

Metabolic parameters are lipid profile (cholesterol, HDL cholesterol LDL cholesterol and triglycerides) in mg/dl. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

Time frame
2 years
3

Renal function evaluation of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ.

Renal function in mg/g (albumin/creatinine ratio). Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

Time frame
2 years
4

Self-care evaluation of the cases attended at the Center compared with those of patients with similar characteristics attended in the "Internal Medicine" service of the INCMNSZ.

Self-care evaluation will be determined by SDSCA questionnaire and an objective examination of the patient doing the activities. Comparison will be with patients from the Internal Medicine ward, who meet the same clinical characteristics as the patients from the Center.

Time frame
2 years

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