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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
404
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.
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.
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.
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).
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.
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
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
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).
Time frame: 24-months post-intervention
Measures of "Common Effect"
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.
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
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.
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 Targets: SCL-20 Score
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.
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 Targets: HbA1c
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.
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 Targets: SBP
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.
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 Targets: LDL-c in mg/dl
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.
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 Individual Risk Factors: SCL-20
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.
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 Individual Risk Factors: Glycemic Control
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.
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 Individual Risk Factors: Blood Pressure
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.
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 Individual Risk Factors: Lipid Control
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.
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Treatment Satisfaction Scores
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.
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Health Expenditures (Direct Medical Costs)
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.
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Cost Utility in the Treatment Arm and Usual Care Arms
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.
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
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