INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
NCT ID: NCT02022111
Last Updated: 2021-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
404 participants
INTERVENTIONAL
2014-03-31
2019-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention Program of Care
1. Patient Education and Behavioral Activation by a Care Coordinator;
2. Supporting Self-Care;
3. Psychiatrist and Diabetologist Reviews; and
4. Decision-support Electronic Health Record System
Patient Education and Behavioral Activation
To stimulate and motivate sustained, effective self-care, patient education materials and behavioral activation techniques that are adapted for the Indian population will be used by care coordinators. Behavioral activation strategies are brief, structured psychological interventions that are based on extensive theoretical and clinical literature, can be delivered by non-specialist providers, can be combined with antidepressant medications, and emphasize reinforcing behaviors to produce improvements in thoughts, mood, and quality of life.
Supporting Self-Care (care coordinators)
Care coordinators will: (a) meet with intervention arm patients and collaboratively set treatment goals; (b) provide verbal education regarding diabetes and depression self-care ;(c) will use motivational interviewing and self-efficacy enhancement strategies to promote monitoring of depressive symptoms, glucose, BP; (d) will proactively follow-up to externally monitor depression symptoms and CVD indicators; (e) will enter updated patient indicators into decision-support electronic health record and utilize software outputs to prioritize patients for review; (g) will convene case review meetings with supervising physicians; and (h) will communicate physician-recommended treatment changes to patients and their routine providers.
Psychiatrist and Diabetologist Reviews
Senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline case review meetings with care coordinators. Case review meetings will be structured: the decision-support electronic health record will help prioritize cases that are new (within 3 weeks of randomization); have moderate/severe depression symptoms (based on Patient Health Questionnaire (PHQ)-9) ≥6 weeks after most recent treatment changes, or continued poor HbA1c, home glucose, BP, or LDL-c control in past 4 weeks; or have not been reviewed for 3 months. Based on patient indicators and current therapies, physicians will recommend treatment changes (initiation, increases, or simplification of medication regimens) which will be communicated by care coordinators to patients and their usual care providers.
Decision-support Electronic Health Record System
The decision-support electronic health record will store patient indicators entered by the Nurse Case Managers (NCM) and provide diabetes and depression care prompts based on an evidence-based treatment algorithm developed from recommended guidelines for control of diabetes and depression, Indian formularies, and TeamCare investigators. The decision-supported electronic health record (DS-EHR) will prioritize patients (new; poorly-controlled; or well-controlled but not reviewed ≥3 months) for case review meetings and promote accountability (physicians must justify rejecting electronic care prompts).
Control Arm
Participants randomized to the control arm will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Standard of Care
Participants randomized to the control arm will receive the existing standard care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Interventions
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Patient Education and Behavioral Activation
To stimulate and motivate sustained, effective self-care, patient education materials and behavioral activation techniques that are adapted for the Indian population will be used by care coordinators. Behavioral activation strategies are brief, structured psychological interventions that are based on extensive theoretical and clinical literature, can be delivered by non-specialist providers, can be combined with antidepressant medications, and emphasize reinforcing behaviors to produce improvements in thoughts, mood, and quality of life.
Supporting Self-Care (care coordinators)
Care coordinators will: (a) meet with intervention arm patients and collaboratively set treatment goals; (b) provide verbal education regarding diabetes and depression self-care ;(c) will use motivational interviewing and self-efficacy enhancement strategies to promote monitoring of depressive symptoms, glucose, BP; (d) will proactively follow-up to externally monitor depression symptoms and CVD indicators; (e) will enter updated patient indicators into decision-support electronic health record and utilize software outputs to prioritize patients for review; (g) will convene case review meetings with supervising physicians; and (h) will communicate physician-recommended treatment changes to patients and their routine providers.
Psychiatrist and Diabetologist Reviews
Senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline case review meetings with care coordinators. Case review meetings will be structured: the decision-support electronic health record will help prioritize cases that are new (within 3 weeks of randomization); have moderate/severe depression symptoms (based on Patient Health Questionnaire (PHQ)-9) ≥6 weeks after most recent treatment changes, or continued poor HbA1c, home glucose, BP, or LDL-c control in past 4 weeks; or have not been reviewed for 3 months. Based on patient indicators and current therapies, physicians will recommend treatment changes (initiation, increases, or simplification of medication regimens) which will be communicated by care coordinators to patients and their usual care providers.
Decision-support Electronic Health Record System
The decision-support electronic health record will store patient indicators entered by the Nurse Case Managers (NCM) and provide diabetes and depression care prompts based on an evidence-based treatment algorithm developed from recommended guidelines for control of diabetes and depression, Indian formularies, and TeamCare investigators. The decision-supported electronic health record (DS-EHR) will prioritize patients (new; poorly-controlled; or well-controlled but not reviewed ≥3 months) for case review meetings and promote accountability (physicians must justify rejecting electronic care prompts).
Standard of Care
Participants randomized to the control arm will receive the existing standard care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
* PHQ-9 score≥10
* ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used
* Willingness to consent to randomization.
Exclusion Criteria
* Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
* Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)
* Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
* Pregnancy or breastfeeding
* Documented CVD event (MI, stroke) in past 12 months
* End-stage renal disease awaiting transplant
* Malignancy or life-threatening disease with death probable in 3 years
* Alcohol or drug abuse
* No fixed address or contact details.
35 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Madras Diabetes Research Foundation
OTHER
All India Institute of Medical Sciences
OTHER
Endocrine & Diabetes Centre
UNKNOWN
Diacon Hospital
OTHER
Emory University
OTHER
Responsible Party
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Mohammed K Ali, MD, MSc, MBA
Associate Professor
Principal Investigators
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Viswanathan Mohan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dr Mohan's Diabetes Specialities Clinic
Mohammed K Ali, MBChB, MSc
Role: PRINCIPAL_INVESTIGATOR
Emory University
Lydia Chwastiak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Diacon Hospital, Diabetes Care and Research Center
Bangalore, , India
Madras Diabetes Research Foundation
Chennai, , India
All India Institute of Medical Sciences
Delhi, , India
Endocrine Diabetes Center
Visakhapatnam, , India
Countries
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References
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Donabedian A. The end results of health care: Ernest Codman's contribution to quality assessment and beyond. Milbank Q. 1989;67(2):233-56; discussion 257-67.
Detsky AS, Naglie IG. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990 Jul 15;113(2):147-54. doi: 10.7326/0003-4819-113-2-147.
Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
CARRS Trial Writing Group; Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, Viswanathan V, Masood Q, Bantwal G, Khadgawat R, Desai A, Sethi BK, Shivashankar R, Ajay VS, Reddy KS, Narayan KM, Prabhakaran D, Tandon N. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012 Nov;98(2):285-94. doi: 10.1016/j.diabres.2012.09.023. Epub 2012 Oct 22.
Halliday S, Rao D, Augusto O, Poongothai S, Sosale A, Sridhar GR, Tandon N, Sagar R, Patel SA, Narayan KMV, Johnson LCM, Wagenaar BH, Huh D, Flaherty BP, Chwastiak LA, Ali MK, Mohan V; INDEPENDENT Study Group. A mediation analysis evaluating change in self-stigma on diabetes outcomes among people with depression in urban India: A secondary analysis from the INDEPENDENT trial of the collaborative care model. PLOS Glob Public Health. 2024 Sep 4;4(9):e0003624. doi: 10.1371/journal.pgph.0003624. eCollection 2024.
Hassan S, Liu S, Johnson LCM, Patel SA, Emmert-Fees KMF, Suvada K, Tandon N, Sridhar GR, Aravind S, Poongothai S, Anjana RM, Mohan V, Chwastiak L, Ali MK. Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study. Prim Care Diabetes. 2024 Jun;18(3):319-326. doi: 10.1016/j.pcd.2024.02.001. Epub 2024 Feb 15.
Suvada K, Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kasuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V, Patel SA. Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. J Gen Intern Med. 2023 May;38(7):1623-1630. doi: 10.1007/s11606-022-07958-8. Epub 2023 Jan 3.
Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Patel SA, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kosuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V; INDEPENDENT Study Group. Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):651-662. doi: 10.1001/jama.2020.11747.
Kowalski AJ, Poongothai S, Chwastiak L, Hutcheson M, Tandon N, Khadgawat R, Sridhar GR, Aravind SR, Sosale B, Anjana RM, Rao D, Sagar R, Mehta N, Narayan KMV, Unutzer J, Katon W, Mohan V, Ali MK. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India. Contemp Clin Trials. 2017 Sep;60:113-124. doi: 10.1016/j.cct.2017.06.013. Epub 2017 Jun 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00064913
Identifier Type: -
Identifier Source: org_study_id
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