Status:
COMPLETED
Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression
Lead Sponsor:
Alicia Monreal Bartolomé
Collaborating Sponsors:
Universidad de Zaragoza
Conditions:
Diabetes Mellitus, Type 2
Depression
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 interve...
Detailed Description
Patients with diabetes mellitus have a depression rate 1.6-2 times higher, impaired quality of life and increased mortality rates due to complications, comorbid depression or both. Prognosis in diabet...
Eligibility Criteria
Inclusion
- Adult individuals (21+).
- Concurrent type 2 diabetes (T2D) and depression diagnose registered in the SALUD clinical computerised system before January 1st, 2016.
- A duration of both T2D and depression of at least one year.
- Willingness to follow the TELE-DD research nurse instructions including self-monitoring of blood glucose.
- Fluent in the Spanish language
- Provision of signed and dated informed consent prior to any study procedures.
- No treatment adherence to both T2D and depression, or treatment adherence to both.
Exclusion
- Presence of hearing problems, Alzheimer Disease, dementia or another serious cognitive or psychiatric disorder.
- Use of private health insurance that may influence the RCT intervention outcomes.
- Absence of pharmacological treatment for T2D or depression according to the CHS-EMR.
- Change of address or place of residence out of SALUD Zaragoza Region II, or no access to a phone.
- No Primary Care Specialist (PCS) or inability to identify a reference one.
- Treatment adherence only for one of the two conditions (D2T or depression).
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT04097483
Start Date
January 1 2017
End Date
March 1 2020
Last Update
February 16 2021
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