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Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression

NCT04097483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2021-02-16

No results posted yet for this study

Summary

Patients with diabetes have higher depression rates, impaired QOL and increased mortality rates due to complications and comorbid depression. Nurse-led, telephonic-based, and psychoeducational interventions have separately proved to improve disease prognosis and emotional distress in diabetes, but no study has integrated previous research findings with collaborative care and strong methods centred in treatment adherence outcomes. The Telephonic Monitoring on Diabetes and co-morbid Depression (TELE-DD) Project includes a three-phased population-based cohort study and nurse-led randomised controlled trial. The proposed intervention, based on monthly structured telephone calls, unifies proved techniques like motivational interviewing, cognitive behavioural therapy and patient's healthy behaviours education.

The integration in the TELE-DD Project of previous clinical research and a robust epidemiological dual design, will improve treatment adherence and further prognosis in patients with type 2 diabetes and comorbid depression through maximising clinical outcomes improvement, while guaranteeing cost-effectiveness and the long-term sustainability of findings translation to PC clinical practice services and public health programs.

Conditions

Interventions

BEHAVIORAL

Telephone Intervention Group

Nurse-led, telephone-based, and psychoeducational intervention centered on motivational interviewing and cognitive behavioral therapy for adherence and depression.

Sponsors & Collaborators

  • Universidad de Zaragoza

    collaborator OTHER

  • Alicia Monreal Bartolomé

    lead OTHER

Principal Investigators

  • María-Luisa Lozano-del-Hoyo, MSc · Universidad de Zaragoza

  • María-Teresa Fernández-Rodrigo, PhD · Universidad de Zaragoza

  • Juan F Roy, PhD · Camilo Jose Cela University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2020-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097483 on ClinicalTrials.gov