Alcohol MisuseACME-TMNCT04838457
Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease
A study testing Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) in people with Alcohol Misuse and Hypertension, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse, Hypertension, Elevated Cardiovascular Risk
- What is being tested?
- Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.
- Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
- Uncontrolled BP (indicated by average outpatient past year systolic BP of >140/100mmHg). > 1 measurement required.
- Currently prescribed at least one oral medication for hypertension, hyperlipidemia, and/or diabetes mellitus as evidenced by at least one pharmacy refill within the previous year.
- Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
- Self-reported access to any SMS text-capable phone.
- Appropriate medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
Who cannot join
- Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
- Current participation in other alcohol misuse treatment programming.
- EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
- Any recent or impending procedures that would warrant inpatient hospital stays or considerable changes to current medications (e.g., any changes other than altered doses).
- Current palliative care or care through a nursing/hospice home.
- History of clinically significant alcohol withdrawal symptoms, as evidenced by a score 10 on the CIWA.
- Contraindicated medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)
The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.
Read the detailed description
Specific Aims: Aim 1 -Characterize a national cohort of Veterans with alcohol misuse and modifiable CVD risk, their alcohol services utilization, and clinical outcomes. Aim 2 - Qualitatively assess barriers to treatment for Veterans with alcohol misuse and CVD risk across multiple stakeholders. Aim 3 - Use a successive cohort design to iteratively develop an intervention based on patient feedback. Aim 4 - Test the acceptability and feasibility of an intervention to reduce alcohol misuse and CVD risk in Veterans.
Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention.
- Conditions
- Alcohol Misuse, Hypertension, Elevated Cardiovascular Risk
- Being tested
- Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)
- Keywords
- Alcohol, Cardiovascular Disease, Telehealth, Cognitive Behavioral Therapy, SMS Text
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)Behavioural
Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.
| Study group | Role | What they receive |
|---|---|---|
| ACME-TM | Experimental | Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors. Receives: Behavioral: Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Feasibility
Intervention and trial feasibility will be evaluated by tracking patient recruitment (feasibility of enrollment; proportion contacted/proportion enrolled and consented).
Measured: Baseline Only
Treatment Feasibility
Intervention and trial feasibility will be evaluated by tracking patient adherence/retention during treatment (feasibility of treatment; adherence cutoff of 75% of sessions).
Measured: 10 Weeks Post-Baseline
Treatment Acceptability
Acceptability will be measured by the Treatment Acceptability and Preferences (TAP). Post-treatment, patients will complete the TAP measure and open-ended questions to assess their knowledge about their conditions, experiences with treatment, and satisfaction.
Measured: 10 Weeks Post-Baseline
Therapist Fidelity
Therapist fidelity will be measured by structured independent ratings of a random sample of 20% of recordings using the Yale Adherence and Competence Scale (YACS).
Measured: 6 Weeks Post-Baseline
SMS Text Acceptability
SMS text utilization metrics (read reports on 75% of texts, or affirmative responses to receipt of 75% of texts) and open-ended post-treatment responses will be used to measure SMS text acceptability.
Measured: 10 Weeks Post-Baseline
Secondary outcomes (3)
Systolic Blood Pressure
Three measures at 1-minute intervals will be obtained using electronic BP cuffs after patients rest for 5 minutes. BP values for each time point will be the average of the 3 measures. Reductions of 5 mmHg will be considered clinically significant.
Measured: 6 months Post-Baseline
Past-Month Self-Reported Heavy Drinking Days
Past month self-reported days (via Timeline Follow-back, with heavy drinking defined as 5 drinks (men), 3 drinks (women)) over the previous month will be measured.
Measured: 6 months Post-Baseline
ReComp Pharmacy Refill Compliance Estimate for CVD medications
Aggregated 3-month (90 day), and 6-month (180 day) adherence will be calculated on pharmacy refill data across all CVD medications, including antihypertensives, statins, and oral hypoglycemics. Refill rates will be calculated using the modified ReComp definition.
Measured: 6 months Post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Dec 2021
- Primary completion30 May 2025
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The interventional model takes place in two parts. Part 1 is a successive cohort design in which a small cohort of participants complete the treatment, and provide qualitative and quantitative feedback on the treatment. The treatment process is then revised accordingly. A second and third cohort of participants complete treatment, followed by the same revision process. Part 2 involves a single-arm pilot trial of acceptability and feasibility of recruiting methods, treatment, and measurement of outcomes for participants.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel Blalock, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838457
- Sponsor's protocol ID
- CDX 21-005
- Acronym
- ACME-TM
- Status last verified
- May 2026
- First submitted
- 6 Apr 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)
- ClinicalTrials.gov ID
- NCT04838457
- Acronym / sponsor ID
- ACME-TM / CDX 21-005
- Conditions
- Alcohol Misuse, Hypertension, Elevated Cardiovascular Risk
- Keywords
- Alcohol, Cardiovascular Disease, Telehealth, Cognitive Behavioral Therapy, SMS Text
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.
Detailed description
Specific Aims: Aim 1 -Characterize a national cohort of Veterans with alcohol misuse and modifiable CVD risk, their alcohol services utilization, and clinical outcomes. Aim 2 - Qualitatively assess barriers to treatment for Veterans with alcohol misuse and CVD risk across multiple stakeholders. Aim 3 - Use a successive cohort design to iteratively develop an intervention based on patient feedback. Aim 4 - Test the acceptability and feasibility of an intervention to reduce alcohol misuse and CVD risk in Veterans.
Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The interventional model takes place in two parts. Part 1 is a successive cohort design in which a small cohort of participants complete the treatment, and provide qualitative and quantitative feedback on the treatment. The treatment process is then revised accordingly. A second and third cohort of participants complete treatment, followed by the same revision process. Part 2 involves a single-arm pilot trial of acceptability and feasibility of recruiting methods, treatment, and measurement of outcomes for participants.
| Arm | Type | Receives |
|---|---|---|
| ACME-TM | Experimental | Behavioral: Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.
- Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
- Uncontrolled BP (indicated by average outpatient past year systolic BP of >140/100mmHg). > 1 measurement required.
- Currently prescribed at least one oral medication for hypertension, hyperlipidemia, and/or diabetes mellitus as evidenced by at least one pharmacy refill within the previous year.
- Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
Key exclusion criteria (7 listed)
- Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
- Current participation in other alcohol misuse treatment programming.
- EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
- Any recent or impending procedures that would warrant inpatient hospital stays or considerable changes to current medications (e.g., any changes other than altered doses).
- Current palliative care or care through a nursing/hospice home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors. | Behavioural | ACME-TM |
Primary outcome
Enrollment Feasibility
Time frame: Baseline Only
Intervention and trial feasibility will be evaluated by tracking patient recruitment (feasibility of enrollment; proportion contacted/proportion enrolled and consented).
Treatment Feasibility
Time frame: 10 Weeks Post-Baseline
Intervention and trial feasibility will be evaluated by tracking patient adherence/retention during treatment (feasibility of treatment; adherence cutoff of 75% of sessions).
Treatment Acceptability
Time frame: 10 Weeks Post-Baseline
Acceptability will be measured by the Treatment Acceptability and Preferences (TAP). Post-treatment, patients will complete the TAP measure and open-ended questions to assess their knowledge about their conditions, experiences with treatment, and satisfaction.
Therapist Fidelity
Time frame: 6 Weeks Post-Baseline
Therapist fidelity will be measured by structured independent ratings of a random sample of 20% of recordings using the Yale Adherence and Competence Scale (YACS).
SMS Text Acceptability
Time frame: 10 Weeks Post-Baseline
SMS text utilization metrics (read reports on 75% of texts, or affirmative responses to receipt of 75% of texts) and open-ended post-treatment responses will be used to measure SMS text acceptability.
3 secondary outcomes
Systolic Blood Pressure
Time frame: 6 months Post-Baseline
Past-Month Self-Reported Heavy Drinking Days
Time frame: 6 months Post-Baseline
ReComp Pharmacy Refill Compliance Estimate for CVD medications
Time frame: 6 months Post-Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Blalock, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) in people with Alcohol Misuse and Hypertension, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Feasibility (time frame: Baseline Only). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.