Trial Outcomes & Findings for Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (NCT NCT03520413)

NCT ID: NCT03520413

Last Updated: 2023-07-27

Results Overview

Laboratory blood test to measure diabetes control

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

12 months

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	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 Persistently Poorly controlled Diabetes Mellitus (PPDM) - into a single, comprehensive program specifically developed for practical delivery using existing Veterans Health Administration (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.	Standard VA Home Telehealth Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Overall Study STARTED	101	99
Overall Study COMPLETED	77	73
Overall Study NOT COMPLETED	24	26

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Persistently Poorly controlled Diabetes Mellitus (PPDM) - into a single, comprehensive program specifically developed for practical delivery using existing Veterans Health Administration (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.	Standard VA Home Telehealth Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	2
Overall Study Death	0	1
Overall Study Physician Decision	3	3
Overall Study Completed a study interview but did not obtain HbA1c data	19	19

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRACTICE-DM n=101 Participants 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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=99 Participants	75 Participants n=107 Participants	151 Participants n=206 Participants
Age, Categorical >=65 years	25 Participants n=99 Participants	24 Participants n=107 Participants	49 Participants n=206 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 8.3 • n=99 Participants	57.8 years STANDARD_DEVIATION 8.0 • n=107 Participants	57.8 years STANDARD_DEVIATION 8.2 • n=206 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	21 Participants n=107 Participants	45 Participants n=206 Participants
Sex: Female, Male Male	77 Participants n=99 Participants	78 Participants n=107 Participants	155 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants n=99 Participants	93 Participants n=107 Participants	188 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	68 Participants n=99 Participants	76 Participants n=107 Participants	144 Participants n=206 Participants
Race (NIH/OMB) White	25 Participants n=99 Participants	17 Participants n=107 Participants	42 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Region of Enrollment United States · Richmond, VA	44 Participants n=99 Participants	41 Participants n=107 Participants	85 Participants n=206 Participants
Region of Enrollment United States · Durham, NC	57 Participants n=99 Participants	58 Participants n=107 Participants	115 Participants n=206 Participants
Baseline Hemoglobin A1c	10.1 % HbA1c STANDARD_DEVIATION 1.2 • n=99 Participants	10.2 % HbA1c STANDARD_DEVIATION 1.4 • n=107 Participants	10.2 % HbA1c STANDARD_DEVIATION 1.3 • n=206 Participants
Body Mass Index (kg/m^2)	34.5 kg/m^2 STANDARD_DEVIATION 6.4 • n=99 Participants	35.2 kg/m^2 STANDARD_DEVIATION 7.0 • n=107 Participants	34.8 kg/m^2 STANDARD_DEVIATION 6.7 • n=206 Participants
Diabetes Distress Scale (DDS)	1.9 units on a scale STANDARD_DEVIATION 0.7 • n=99 Participants	1.9 units on a scale STANDARD_DEVIATION 0.9 • n=107 Participants	1.9 units on a scale STANDARD_DEVIATION 0.8 • n=206 Participants
Diabetes Self-Management Questionnaire (DSMQ)	6.9 units on a scale STANDARD_DEVIATION 1.5 • n=99 Participants	6.5 units on a scale STANDARD_DEVIATION 1.7 • n=107 Participants	6.7 units on a scale STANDARD_DEVIATION 1.6 • n=206 Participants
Self-Efficacy (PCS)	5.2 units on a scale STANDARD_DEVIATION 1.5 • n=99 Participants	5.2 units on a scale STANDARD_DEVIATION 1.4 • n=107 Participants	5.2 units on a scale STANDARD_DEVIATION 1.5 • n=206 Participants
Depression (PHQ-8)	7.0 units on a scale STANDARD_DEVIATION 5.2 • n=99 Participants	7.6 units on a scale STANDARD_DEVIATION 6.1 • n=107 Participants	7.3 units on a scale STANDARD_DEVIATION 5.7 • n=206 Participants

PRIMARY outcome

Timeframe: 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.

Laboratory blood test to measure diabetes control

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Hemoglobin A1c	8.58 % HbA1c Interval 8.22 to 8.94	9.19 % HbA1c Interval 8.83 to 9.55

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Diabetes Distress Scale	1.43 score on a scale Interval 1.3 to 1.56	1.67 score on a scale Interval 1.54 to 1.81

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Diabetes Self-Management Questionnaire	8.34 score on a scale Interval 8.15 to 8.54	7.83 score on a scale Interval 7.63 to 8.03

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Perceived Competence Scale	6.31 score on a scale Interval 6.09 to 6.54	5.92 score on a scale Interval 5.69 to 6.16

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Body Mass Index	35.05 kg/m^2 Interval 34.1 to 36.01	34.86 kg/m^2 Interval 33.91 to 35.82

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PRACTICE-DM n=101 Participants 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 Persistently Poorly controlled Diabetes Mellitus (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.	Standard VA Home Telehealth n=99 Participants Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Patient Health Questionnaire-8	4.64 score on a scale Interval 3.62 to 5.66	5.80 score on a scale Interval 4.75 to 6.85

Adverse Events

PRACTICE-DM

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard VA Home Telehealth

Serious events: 14 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Matthew Crowley, MD

Durham Veterans Affairs Medical Center

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PRACTICE-DM n=101 participants at risk 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.	Standard VA Home Telehealth n=99 participants at risk Standard VA HT care coordination and telemonitoring. Standard VA Home Telehealth: Standard VA HT care coordination and telemonitoring.
Cardiac disorders Hospitalization	0.99% 1/101 • Number of events 2 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	1.0% 1/99 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Endocrine disorders Hospitalization	2.0% 2/101 • Number of events 3 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
General disorders Hospitalization	0.00% 0/101 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	1.0% 1/99 • Number of events 3 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Gastrointestinal disorders Hospitalization	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Infections and infestations Hospitalization	0.00% 0/101 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	4.0% 4/99 • Number of events 4 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Musculoskeletal and connective tissue disorders Hospitalization	2.0% 2/101 • Number of events 3 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	1.0% 1/99 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Immune system disorders Hospitalization	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Nervous system disorders Hospitalization	0.00% 0/101 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	2.0% 2/99 • Number of events 3 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Psychiatric disorders Hospitalization	0.00% 0/101 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	2.0% 2/99 • Number of events 2 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Respiratory, thoracic and mediastinal disorders Hospitalization	2.0% 2/101 • Number of events 4 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	1.0% 1/99 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Surgical and medical procedures Hospitalization	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	2.0% 2/99 • Number of events 2 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Cardiac disorders Important Medical Event	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
General disorders Important Medical Event	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Infections and infestations Important Medical Event	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Renal and urinary disorders Important Medical Event	2.0% 2/101 • Number of events 2 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Respiratory, thoracic and mediastinal disorders Important Medical Event	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	1.0% 1/99 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Surgical and medical procedures Important Medical Event	2.0% 2/101 • Number of events 2 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
General disorders Persistent or Significant Illness	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Persistent or Significant Illness	0.99% 1/101 • Number of events 1 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term	0.00% 0/99 • Adverse events were collected with each patient contact and a systematic review with study outcome visits during the 12month participation. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term