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NCT Number: NCT02022111

INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

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.

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Key information

Conditions

Diabetes Behavior Behavioral Symptoms Cardiovascular Risk Factor Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diacon Hospital, Diabetes Care and Research Center, Bangalore, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Education and Behavioral Activation

Behavioral

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)

Behavioral

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

Other

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

Other

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

Other

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 outcomes

  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 outcomes

  1. Measures of "Common Effect"

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    The measure of common effect is a modeled composite estimate of patients achieving simultaneous improvements at 12, 24, and 36 months in the continuous measures for the 4 main outcomes of the trial: depression (20-item Symptoms Checklist [SCL-20] score), glycemia (percentage points in hemoglobin A1c), blood pressure (mmHg of BP), and lipids (mg/dl of LDL-cholesterol).The components of the common effect were standardized differences in each continuous outcome. At each time point, the z-score of each outcome was computed. Next, a model was run to examine the average difference between treatment (intervention) and control in the average level of the standardized outcomes. The estimates are z-score differences in the composite continuous measures of the SCL-20, hemoglobin A1c, systolic BP, and LDL-cholesterol and so, if the intervention group was significantly different (or lower) than the values for the usual care group (control arm), then, the estimates would be negative.

  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

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    This outcome was an estimate of mean change, from baseline, of the 20-item Symptoms Checklist Depression Scale (SCL-20; range 0-4; higher scores indicate worse symptoms) for the intervention and usual care groups. The outcome was reported as a change in score from baseline at 12 months, 24 months, and 36 months with 95% confidence intervals.

  4. Mean Changes in Each of the Four Main Targets: HbA1c

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    This outcome looked at mean change in one of the four main target outcome indicators: HbA1c in percentage points between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

  5. Mean Changes in Each of the Four Main Targets: SBP

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    This outcome looked at mean change in one of the four main target outcome indicators: Systolic blood pressure (SBP) in mmHg between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

  6. Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    This outcome looked at mean change in one of the four main target outcome indicators: LDL-c in mg/dl between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.

  7. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    Proportion of participants achieving treatment target or significant reductions in depression control: ≥50% reduction in SCL-20 at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

  8. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control

    Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)

    Proportion of participants achieving a treatment target of HbA1c ≤ 7.0% or ≥ 0.5% reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

  9. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure

    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 of blood pressure (BP) control: Systolic blood pressure (SBP) ≤ 130 mmHg or ≥5 mmHg reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

  10. Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control

    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 of lipid control: LDL ≤ 100 mg/dl or ≥ 10mg/dl reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.

  11. 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. Score range is 0-6. Higher score is associated with better outcome.

  12. 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.

  13. 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). The within-trial cost-utility of intervention was compared to usual care, an incremental cost-utility ratio will be calculated [net costs to net utility: costs(intervention) - costs(control) / utility(intervention) - utility(control)]. The chosen measure of utility is the closest option to a global measure, the quality adjusted life year [QALY] and is calculated as the sum of mean survival time [life years] x utility scores at 6, 12, 18, 24 and 36 months.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • All India Institute of Medical Sciences
  • Diacon Hospital
  • Endocrine & Diabetes Centre
  • Madras Diabetes Research Foundation
  • National Institute of Mental Health (NIMH)
  • University of Washington

Registry information

Acronym: INDEPENDENT

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Dec 27, 2013
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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