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

NCT ID: NCT04097483

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-03-31

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 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.

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 diabetes and depression comorbidity can be improved by increasing treatment adherence. Nurse-led, telephonic-based, and psychoeducational interventions, centred on motivational interviewing and cognitive behavioural therapy for adherence and depression, have separately improved prognosis and emotional distress in diabetic patients with comorbid depression.

The Telephonic Monitoring on Diabetes and co-morbid Depression (TELE-DD) Project aims to integrate prior well-stablished clinical research with collaborative care. A whole population cohort of adults (21+) with type 2 diabetes (T2D) and comorbid depression from twenty-three Health Centres from a whole Health System Region in Spain, will be approached for inclusion in the TELE-DD Project (N=7,271). Patients with confirmed diagnoses and pharmacological treatment for both diseases will be included in Phase I baseline cohort. In Phase II, 400 participants diagnosed with depression and T2D with no treatment adherence will be selected to participate in the randomised controlled trial (RCT). The TELE-DD Project is a three-stage both observational and comparative effectiveness study that includes a population-based cohort study (Phases I and III), and a nurse-led randomised controlled trial (Phase II), aimed to compare a telephonic-based psychoeducational intervention (TIG) vs treatment as usual (TAU) to improve treatment adherence (TA), and a further two- to five-year prognosis and cost-effectiveness study, in T2D patients with comorbid clinical depression from Primary Care (PC) services.

The integration in the TELE-DD Project of previous clinical research and a robust epidemiological design, will improve treatment adherence and further prognosis in these 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

Diabetes Mellitus, Type 2; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telephone Intervention Group

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

Group Type: EXPERIMENTAL

Telephone Intervention Group

Intervention Type: BEHAVIORAL

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

Control group

Control group with treatment as usual (TAU).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telephone Intervention Group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Alicia Monreal Bartolomé

OTHER

Sponsor Role: lead

Responsible Party

Alicia Monreal Bartolomé

MS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

María-Luisa Lozano-del-Hoyo, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

María-Teresa Fernández-Rodrigo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Juan F Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Camilo Jose Cela University

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Other Identifiers

TELE-DD

Identifier Type: -

Identifier Source: org_study_id