Effect of the Teleconsultation of Renal Nutrition on Renal Function and Glycemic Control in Patients With DKD

NCT03344549 | Completed Results DMC

• 1 other identifier: HCN001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The modern era is characterized by progress, development and social and economic globalization. Currently the electronic technology has applications in a wide variety of work areas. A clear example of this, is telemedicine. The technological tools are increasingly used every day in the improvement of the processes and the attention in health, in the last decades, telemedicine has grown exponentially becoming more accessible to the population. On the other hand, and in the same way, the number of people with chronic degenerative diseases such as diabetes and chronic kidney disease are increasing with alarming numbers, The health system can not offer the attention to the great demand. The strategies used until now for its management have gradually evolved towards a more effective prevention and treatment approach which requires a multidisciplinary team. Investigate the use of new tools that promise to improve the service, has also become a prevailing need. Therefore, the purpose of this study is to know the effect of nutritional teleconsultation on renal function and glycemic control of patients with Diabetic Kidney Disease (DKD) in pre-dialysis stages (specifically G3a, G3b and G4).

Conditions

Diet Modification; Diabetic Kidney Disease; Chronic Kidney Diseases

Keywords

eHealth; Nutrition Therapy; Telehealth; Diabetic Kidney Disease; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Glycemic Control

  Determination of glycated hemoglobin (HbA1c) levels at the beginning and end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.

  Baseline and at 4 month

• Renal Function

  Determination of the estimated glomerular filtration rate (eGFR), at the end of the nutritional intervention through teleconsultation and face-to-face consultation offered monthly for 4 months.

  Baseline and at 4 month

Secondary Outcomes (1)

• Number of Participants With Adherence to Treatment

  Baseline and at 5 month

Study Arms (2)

Teleconsultation

EXPERIMENTAL

In the patients of the experimental group, the nutritional intervention is carried out through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic).

Behavioral: Renal nutrition teleconsultation

Face-to-face consultation

OTHER

In the patients of the other group, the nutritional intervention is offered through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution.

Behavioral: Face-to-face consultation of renal nutrition

Interventions

Renal nutrition teleconsultation BEHAVIORAL

Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.

Teleconsultation

Face-to-face consultation of renal nutrition BEHAVIORAL

Face-to-face consultation of renal nutrition for patients with diabetic kidney disease without dialysis, monthly for 4 months.

Face-to-face consultation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetic kidney with eGFR \<60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively).
• Patients who can read and write.
• Patients who have access to the internet and have a computer, tablet or smartphone.
• Patients who signed the voluntary agreement to participate.

You may not qualify if:

• Patients who have received prior nutritional treatment for the control of diabetic kidney disease.
• Patients with actual consumption of food supplements and / or keto analogues.
• Patients with anemia or recent transfusions (in the last 3 months).
• Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).
• Patients with serious difficulties in communication or intellectual deficit that impedes the ability to understand the intervention.
• Patients with refractory arterial hypertension.
• Patients who do not attend ≥ 2 nutritional interventions.
• Patients who present serious complications during the intervention (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, etc.).

Sponsors & Collaborators

• Hospital Civil Juan I. Menchaca: lead

Study Sites (1)

Hospital Civil Nuevo Juan I Menchaca

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (20)

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  PMID: 21832984 BACKGROUND

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  PMID: 24405907 BACKGROUND

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  PMID: 26305666 BACKGROUND

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  PMID: 23508602 BACKGROUND

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  PMID: 26398645 BACKGROUND

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Related Links

• National Survey of Occupation and Employment, 2016

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ari Cisneros Hernández
• Organization: University of Colima

aricisneroshernandez@gmail.com

3335762299

Study Officials

• Ari Cisneros, Bachelor

  Hospital Civil Juan I. Menchaca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ari Cisneros Hernández

Model Details: In the experimental group, the nutritional intervention will be done through teleconsultation with the free technological tool chosen (the patients from home and the nutritionist from the remote clinic); and in the control group will be offered the nutritional intervention through face-to-face consultations carried out by the nutritionist of the nutrition service of the institution, both arms will be intervened monthly for four months, the duration of the sessions will be 45 minutes and will include evaluation or re-evaluation of dietary data, diagnosis, treatment and educational approach.

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 17, 2017
• Study Start: December 28, 2017
• Primary Completion: October 25, 2021
• Study Completion: October 30, 2021
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)