Skip to content

Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus

Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03520413
Acronym
PRACTICE-DM
Enrollment
200
Registered
2018-05-09
Start date
2018-12-21
Completion date
2021-02-01
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telemedicine

Keywords

Complex Care, Outcomes, Telemedicine, Rural Health, Diabetes

Brief summary

Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.

Detailed description

This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care. Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. The investigators define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for \>1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs. While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate. The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM. Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond, Virginia (VA)) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care. The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring. Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.

Interventions

OTHERPRACTICE-DM

Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.

OTHERStandard VA Home Telehealth

Standard VA HT care coordination and telemonitoring.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Because participants will receive information on both study arms during the consent process, we will not attempt to blind participants to randomization assignment. However, in order to assure blinding of the staff that manage outcome data collection, randomization (including participant notification of group assignment by phone) will be managed by the project coordinator.

Intervention model description

VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, & Depression support

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none \<8.5%) despite 1 or more appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this period.

Exclusion criteria

* age \>70 * life expectancy \<5 years, or other comorbidities that would offset the benefits of HbA1c \<8.5% * inability to communicate by telephone * dementia or psychosis * active alcohol/substance disorder * pregnancy * prior hypoglycemic seizure/coma * refusal to perform self-monitored blood glucose (SMBG) * use of insulin infusion pumps * hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12m * receiving kidney dialysis * metastatic cancer diagnosis * use of a continuous blood glucose monitor (due to HT equipment constraints) * primary provider requests patient not participate

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c12 monthsLaboratory blood test to measure diabetes control

Secondary

MeasureTime frameDescription
Diabetes Distress Scale12 monthsMeasure of diabetes distress and burden using the Diabetes Distress Scale (DDS). 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.
Diabetes Self-Management Questionnaire12 monthsMeasure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ). 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.
Perceived Competence Scale12 monthsMeasure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS). 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater confidence.
Body Mass Index6 monthsMeasure of weight at 6months due to low number of 12month in person visits permitting data collection as a result of coronavirus disease 2019 (COVID-19) restrictions
Patient Health Questionnaire-812 monthsMeasure of depressive symptoms, Patient Health Questionnaire depression scale (PHQ8). 8 items, Scale 0-3, Scoring average of responses 0-24. Higher score indicates greater depressive symptoms.

Countries

United States

Participant flow

Participants by arm

ArmCount
PRACTICE-DM
PRACTICE-DM is a comprehensive telemedicine intervention that bundles telemonitoring, self-management support, diet/activity support, medication management, and depression support - each of which targets a critical factor underlying PPDM - into a single, comprehensive program specifically developed for practical delivery using existing VHA Home Telehealth (HT) workforce, infrastructure, and technical resources. PRACTICE-DM: Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.
101
Standard VA Home Telehealth
Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
99
Total200

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCompleted a study interview but did not obtain HbA1c data1919
Overall StudyDeath01
Overall StudyLost to Follow-up11
Overall StudyPhysician Decision33
Overall StudyWithdrawal by Subject12

Baseline characteristics

CharacteristicPRACTICE-DMStandard VA Home TelehealthTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
25 Participants24 Participants49 Participants
Age, Categorical
Between 18 and 65 years
76 Participants75 Participants151 Participants
Age, Continuous57.7 years
STANDARD_DEVIATION 8.3
57.8 years
STANDARD_DEVIATION 8
57.8 years
STANDARD_DEVIATION 8.2
Baseline Hemoglobin A1c10.1 % HbA1c
STANDARD_DEVIATION 1.2
10.2 % HbA1c
STANDARD_DEVIATION 1.4
10.2 % HbA1c
STANDARD_DEVIATION 1.3
Body Mass Index (kg/m^2)34.5 kg/m^2
STANDARD_DEVIATION 6.4
35.2 kg/m^2
STANDARD_DEVIATION 7
34.8 kg/m^2
STANDARD_DEVIATION 6.7
Depression (PHQ-8)7.0 units on a scale
STANDARD_DEVIATION 5.2
7.6 units on a scale
STANDARD_DEVIATION 6.1
7.3 units on a scale
STANDARD_DEVIATION 5.7
Diabetes Distress Scale (DDS)1.9 units on a scale
STANDARD_DEVIATION 0.7
1.9 units on a scale
STANDARD_DEVIATION 0.9
1.9 units on a scale
STANDARD_DEVIATION 0.8
Diabetes Self-Management Questionnaire (DSMQ)6.9 units on a scale
STANDARD_DEVIATION 1.5
6.5 units on a scale
STANDARD_DEVIATION 1.7
6.7 units on a scale
STANDARD_DEVIATION 1.6
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants5 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
95 Participants93 Participants188 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
68 Participants76 Participants144 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants5 Participants9 Participants
Race (NIH/OMB)
White
25 Participants17 Participants42 Participants
Region of Enrollment
United States
Durham, NC
57 Participants58 Participants115 Participants
Region of Enrollment
United States
Richmond, VA
44 Participants41 Participants85 Participants
Self-Efficacy (PCS)5.2 units on a scale
STANDARD_DEVIATION 1.5
5.2 units on a scale
STANDARD_DEVIATION 1.4
5.2 units on a scale
STANDARD_DEVIATION 1.5
Sex: Female, Male
Female
24 Participants21 Participants45 Participants
Sex: Female, Male
Male
77 Participants78 Participants155 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1011 / 99
other
Total, other adverse events
0 / 1010 / 99
serious
Total, serious adverse events
15 / 10114 / 99

Outcome results

Primary

Hemoglobin A1c

Laboratory blood test to measure diabetes control

Time frame: 12 months

Population: Mixed models were used to analyze outcomes. This methodology uses all observations from baseline and the follow-up timepoints. Therefore 200 observations were included at baseline and 150 observations at 12 months.

ArmMeasureValue (MEAN)
PRACTICE-DMHemoglobin A1c8.58 % HbA1c
Standard VA Home TelehealthHemoglobin A1c9.19 % HbA1c
p-value: 0.0295% CI: [-1.12, -0.11]Mixed Models Analysis
Secondary

Body Mass Index

Measure of weight at 6months due to low number of 12month in person visits permitting data collection as a result of coronavirus disease 2019 (COVID-19) restrictions

Time frame: 6 months

ArmMeasureValue (MEAN)
PRACTICE-DMBody Mass Index35.05 kg/m^2
Standard VA Home TelehealthBody Mass Index34.86 kg/m^2
p-value: 0.3995% CI: [-0.24, 0.62]Mixed Models Analysis
Secondary

Diabetes Distress Scale

Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS). 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.

Time frame: 12 months

ArmMeasureValue (MEAN)
PRACTICE-DMDiabetes Distress Scale1.43 score on a scale
Standard VA Home TelehealthDiabetes Distress Scale1.67 score on a scale
p-value: 0.00795% CI: [-0.42, -0.07]Mixed Models Analysis
Secondary

Diabetes Self-Management Questionnaire

Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ). 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.

Time frame: 12 months

ArmMeasureValue (MEAN)
PRACTICE-DMDiabetes Self-Management Questionnaire8.34 score on a scale
Standard VA Home TelehealthDiabetes Self-Management Questionnaire7.83 score on a scale
p-value: 0.000295% CI: [0.25, 0.78]Mixed Models Analysis
Secondary

Patient Health Questionnaire-8

Measure of depressive symptoms, Patient Health Questionnaire depression scale (PHQ8). 8 items, Scale 0-3, Scoring average of responses 0-24. Higher score indicates greater depressive symptoms.

Time frame: 12 months

ArmMeasureValue (MEAN)
PRACTICE-DMPatient Health Questionnaire-84.64 score on a scale
Standard VA Home TelehealthPatient Health Questionnaire-85.80 score on a scale
p-value: 0.195% CI: [-2.53, 0.21]Mixed Models Analysis
Secondary

Perceived Competence Scale

Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS). 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater confidence.

Time frame: 12 months

ArmMeasureValue (MEAN)
PRACTICE-DMPerceived Competence Scale6.31 score on a scale
Standard VA Home TelehealthPerceived Competence Scale5.92 score on a scale
p-value: 0.0295% CI: [0.07, 0.71]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026