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INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study (INDEPENDENT)

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ClinicalTrials.gov Identifier: NCT02022111
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Washington
Madras Diabetes Research Foundation
All India Institute of Medical Sciences, New Delhi
Endocrine & Diabetes Centre
Diacon Hospital
Information provided by (Responsible Party):
Mohammed K Ali, MD, MSc, MBA, Emory University

Brief Summary:
To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at four diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.

Condition or disease Intervention/treatment Phase
Diabetes Depression Cardiovascular Risk Factor Behavioral: Patient Education and Behavioral Activation Behavioral: Supporting Self-Care (care coordinators) Other: Psychiatrist and Diabetologist Reviews Other: Decision-support Electronic Health Record System Other: Standard of Care Not Applicable

Detailed Description:
It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Study Start Date : March 2014
Actual Primary Completion Date : July 14, 2018
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Behavioral: 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.

Behavioral: 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.

Other: 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.

Other: 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).

Placebo Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors [ Time Frame: 24-months post-intervention ]
    The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).


Secondary Outcome Measures :
  1. Measures of "Common Effect" [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Measure of whether the intervention had a similar beneficial effect on 4 targets: SCL-20 score, HbA1c, SBP, and LDL.

  2. Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Proportion of participants in the intervention and usual care groups that achieved all 3 cardiovascular disease risk factor targets: HbA1c≤7.0% and SBP≤130mmHg and LDL≤100 mg/dl.

  3. Mean Changes in Each of the Four Main Targets (SCL-20 Score, HbA1c, SBP, LDL-c) [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Mean changes in each of the four main target outcome indicators (SCL-20 score, HbA1c in percentage points, SBP in mmHg, LDL-c in mg/dl) between the treatment and usual care groups at 12 months and 24 months post-intervention.

  4. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Proportion of participants achieving treatment targets or significant reductions in depression control [≥50% reduction in SCL-20]; glycemic control [HbA1c≤7.0% or ≥0.5% reduction); BP control [SBP≤130mmHg or ≥5 mmHg reduction]; and lipid control [LDL≤100 mg/dl or ≥10mg/dl reduction].

  5. Mean Treatment Satisfaction Scores [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Mean charges in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in the intervention and usual care groups.

  6. Mean Health Expenditures (Direct Medical Costs) [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    Mean of direct medical costs for consultations, diagnostic tests, medications, hospital admissions, and/or surgeries or procedures) among participants in the treatment and usual care groups.

  7. Cost Utility in the Treatment Arm and Usual Care Arms [ Time Frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up) ]
    The ratio of total costs, which include health expenditures by participants plus clinic or study costs to deliver the intervention and the relative gain or loss in health utilities (measured by the health utilities index), in the treatment and usual care arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥35 years
  • 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:

  • The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022111


Locations
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India
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
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
University of Washington
Madras Diabetes Research Foundation
All India Institute of Medical Sciences, New Delhi
Endocrine & Diabetes Centre
Diacon Hospital
Investigators
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Principal Investigator: Viswanathan Mohan, MD, PhD Dr Mohan's Diabetes Specialities Clinic
Principal Investigator: Mohammed K Ali, MBChB, MSc Emory University
Principal Investigator: Lydia Chwastiak, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Mohammed K Ali, MD, MSc, MBA, Emory University:
Informed Consent Form  [PDF] May 29, 2017

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohammed K Ali, MD, MSc, MBA, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02022111    
Other Study ID Numbers: IRB00064913
R01MH100390-01 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2013    Key Record Dates
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders