Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04097483
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2019-09-16
Brief Title:
Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression
Sponsor:
Alicia Monreal Bartolomé
Organization:
Instituto de Investigación Sanitaria Aragón
Study Overview
Official Title:
The TELE-DD Project a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-DD
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 patients 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
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 16-2 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 N7271 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
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 N7271 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None