Diabetes
Conditions
Keywords
Self-Management Support, Depression, Home Telehealth
Brief summary
This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.
Detailed description
Background: Although efforts by VA providers and researchers have improved diabetes care quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type 1 or type 2 diabetes with hemoglobin A1c \>9.0% for \> 1 year despite receipt of medical care) have proven refractory to these widespread improvements, and remain at high risk for complications and accrued costs. Prior research has illustrated that medication regimen complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care do not meet these Veterans' needs. Without the implementation of care delivery strategies that target this population's unique barriers to improved diabetes control, these Veterans will continue to be left behind by progress in diabetes management throughout VA, and will remain at high risk for complications and high costs. We propose using existing local Home Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered, evidence-based intervention combining medication management, self-care behavior support, and depressive symptom management to Veterans with PPDM. Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation strategy, the use of existing Home Telehealth services to administer the intervention; and 3) generate data we will use to refine local intervention implementation and inform the development of an SDP proposal evaluating broader implementation of the Advanced Comprehensive Diabetes Care intervention. Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention (n = 25) or control groups (n = 25). Veterans randomized to the intervention will be enrolled in the Home Telehealth program at Durham VAMC and will receive the study intervention (telehealth-based medication management, self-care behavior support, and depressive symptom management) for 6 months. Intervention-group Veterans with no depression on baseline assessment will not initially receive the depressive symptom management component, but will be monitored for new symptoms throughout the study. Veterans randomized to the control arm will receive diabetes educational materials and management per their primary provider. The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. This RRP will also include a mixed method formative evaluation to qualitatively and quantitatively assess patient-level, provider-level, and organizational barriers and facilitators influencing intervention implementation. Formative evaluation data will be analyzed during the study to consider whether adjustments to the intervention or its implementation may be indicated, and findings will also be used to inform future implementation efforts.
Interventions
BEHAVIORALHome Telehealth with Behavioral Education Component
The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Veterans with type 2 diabetes managed for \> 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment. * We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of \> 9.0% during the past year with no readings of \< 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Control | Baseline, 3months, 6months | Hemoglobin A1c as measured at baseline, 3m, 6m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Medication Adherence | Baseline, 3m, 6m | Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months |
| Diabetes Self Care | Baseline, 3m, 6m | Self-Care Inventory-revised as measured at baseline, 3 months, 6 months |
| Depressive Symptoms | Baseline, 3m, 6m | Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.
Participants by arm
| Arm | Count |
|---|---|
| Control Veterans will receive diabetes educational materials and management per their primary provider | 25 |
| Intervention Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.
Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Transfered care | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 9.2 | 59.9 years STANDARD_DEVIATION 8.7 | 60.2 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 47 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 27 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 13 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 25 Participants | 48 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 25 | 14 / 25 |
| serious Total, serious adverse events | 4 / 25 | 3 / 25 |
Outcome results
Primary
Diabetes Control
Hemoglobin A1c as measured at baseline, 3m, 6m
Time frame: Baseline, 3months, 6months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Diabetes Control | Baseline | 10.7 percentage of glycosylated hemoglobin | Standard Deviation 1.6 |
| Control | Diabetes Control | 3 Months | 10.3 percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
| Control | Diabetes Control | 6 months | 10.4 percentage of glycosylated hemoglobin | Standard Deviation 1.6 |
| Intervention | Diabetes Control | Baseline | 10.2 percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
| Intervention | Diabetes Control | 3 Months | 9.1 percentage of glycosylated hemoglobin | Standard Deviation 1.3 |
| Intervention | Diabetes Control | 6 months | 9.1 percentage of glycosylated hemoglobin | Standard Deviation 2.1 |
Comparison: Comparison at 3 monthsp-value: 0.01295% CI: [-1.7, -0.2]Mixed Models Analysis
Comparison: Comparison at 6 monthsp-value: 0.0595% CI: [-2, 0]Mixed Models Analysis
Secondary
Depressive Symptoms
Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months
Time frame: Baseline, 3m, 6m
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Depressive Symptoms | Baseline | 7.3 units on a scale | Standard Deviation 5.5 |
| Control | Depressive Symptoms | 3 months | 6.6 units on a scale | Standard Deviation 5.1 |
| Control | Depressive Symptoms | 6 months | 5.9 units on a scale | Standard Deviation 4.7 |
| Intervention | Depressive Symptoms | Baseline | 6.9 units on a scale | Standard Deviation 5.6 |
| Intervention | Depressive Symptoms | 3 months | 5.5 units on a scale | Standard Deviation 6.3 |
| Intervention | Depressive Symptoms | 6 months | 6.7 units on a scale | Standard Deviation 6.2 |
Comparison: Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.p-value: 0.42895% CI: [-3.3, 1.4]Mixed Models Analysis
Comparison: Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.p-value: 0.39795% CI: [-1.4, 3.6]Mixed Models Analysis
Secondary
Diabetes Self Care
Self-Care Inventory-revised as measured at baseline, 3 months, 6 months
Time frame: Baseline, 3m, 6m
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Diabetes Self Care | Baseline | 49.8 units on a scale | Standard Deviation 9.6 |
| Control | Diabetes Self Care | 3 months | 53.7 units on a scale | Standard Deviation 10.9 |
| Control | Diabetes Self Care | 6 months | 52.6 units on a scale | Standard Deviation 12.6 |
| Intervention | Diabetes Self Care | Baseline | 52.3 units on a scale | Standard Deviation 14.8 |
| Intervention | Diabetes Self Care | 3 months | 58.2 units on a scale | Standard Deviation 14.6 |
| Intervention | Diabetes Self Care | 6 months | 61.1 units on a scale | Standard Deviation 14 |
Comparison: Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.p-value: 0.30395% CI: [-2.7, 8.4]Mixed Models Analysis
Comparison: Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.p-value: 0.02795% CI: [0.9, 14.4]Mixed Models Analysis
Secondary
Self-reported Medication Adherence
Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months
Time frame: Baseline, 3m, 6m
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Self-reported Medication Adherence | Baseline | 17 participants |
| Control | Self-reported Medication Adherence | 3 months | 11 participants |
| Control | Self-reported Medication Adherence | 6 months | 9 participants |
| Intervention | Self-reported Medication Adherence | Baseline | 15 participants |
| Intervention | Self-reported Medication Adherence | 3 months | 9 participants |
| Intervention | Self-reported Medication Adherence | 6 months | 8 participants |
p-value: 0.8395% CI: [0.35, 2.34]Generalized estimating equation (GEE)
Comparison: Comparison at 6 monthsp-value: 0.9795% CI: [0.33, 3.19]Generalized Estimating Equation (GEE)