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NCT01142908

Cardiovascular Intervention Improvement Telemedicine Study

Completed NA Results posted Last updated 27 July 2023
What this trial tests

NA trial testing Pharmacist CVD in Cardiovascular Disease in 428 participants. Completed in 22 May 2015.

Timeline
1 November 2011
Primary endpoint
30 April 2015
22 May 2015

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment428
Start date1 November 2011
Primary completion30 April 2015
Estimated completion22 May 2015
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Cardiovascular Disease or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) Primary · Baseline

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

GroupValue95% CI
Pharmacist CVD32.4± 18.8
Education Control31.6± 18.6
Mean Systolic Blood Pressure Secondary · Baseline

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD130.6± 18.5
Education Control129.7± 18.8
Mean Systolic Blood Pressure Secondary · 6 months

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD128.3± 16.5
Education Control127.7± 16.8
Mean Systolic Blood Pressure Secondary · 12 months

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD128.5± 15.4
Education Control126.4± 16.2
Mean Diastolic Blood Pressure Secondary · Baseline

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD75.8± 11.5
Education Control75.8± 12.4
Mean Diastolic Blood Pressure Secondary · 6 months

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD74.0± 11.0
Education Control74.1± 11.9
Mean Diastolic Blood Pressure Secondary · 12 months

Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

GroupValue95% CI
Pharmacist CVD73.4± 10.3
Education Control73.1± 10.9
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) Primary · 6 months

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

GroupValue95% CI
Pharmacist CVD30.0± 17.2
Education Control30.2± 18.7
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) Primary · 12 months

Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

GroupValue95% CI
Pharmacist CVD28.9± 15.5
Education Control28.4± 18.3
Medication Non-adherence Secondary · Baseline

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

GroupValue95% CI
Pharmacist CVD137
Education Control110
Medication Non-adherence Secondary · 6 months

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

GroupValue95% CI
Pharmacist CVD92
Education Control85
Medication Non-adherence Secondary · 12 months

First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

GroupValue95% CI
Pharmacist CVD96
Education Control82

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected through out the study from baseline thru completion.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pharmacist CVD
Serious: 126/215 (59%)
Deaths:
Education Control
Serious: 123/213 (58%)
Deaths:

Serious adverse events (82 terms)

ReactionSystemPharmacist CVDEducation Control
Emergency room visitMusculoskeletal and connective tissue disorders
Emergency room visitInfections and infestations
Emergency room visitCardiac disorders
Emergency room visitGeneral disorders
Emergency room visitGastrointestinal disorders
Planned SurgerySurgical and medical procedures
Emergency room visitRespiratory, thoracic and mediastinal disorders
Study Safety ProtocolCardiac disorders
Emergency room visitEndocrine disorders
Coronary IssuesCardiac disorders
InfectionInfections and infestations
Emergency room visitSkin and subcutaneous tissue disorders
Emergency room visitEye disorders
Non_Cardiac PainMusculoskeletal and connective tissue disorders
Emergency room visitPsychiatric disorders
Emergency room visitRenal and urinary disorders
Emergency room visitEar and labyrinth disorders
OrthopedicMusculoskeletal and connective tissue disorders
PsychologicalPsychiatric disorders
Emergency room visitInjury, poisoning and procedural complications
NeurologicNervous system disorders
Emergency room visitReproductive system and breast disorders
PulmonaryRespiratory, thoracic and mediastinal disorders
InfectionSkin and subcutaneous tissue disorders
OrthopedicSurgical and medical procedures

Most-reported serious reactions: Emergency room visit, Emergency room visit, Emergency room visit, Emergency room visit, Emergency room visit, Planned Surgery, Emergency room visit, Study Safety Protocol.

Data from ClinicalTrials.gov NCT01142908 adverse events section.

Sponsor's own description

Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have \> 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of our previous interventions that have demonstrated improved BP, now designed to address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and diabetes. The study focuses on both multiple CVD-related risk factor management and medication management 2) The intervention is multi-behavioral; it addresses patients' various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the intervention will include specific recommendations and transportability of intervention application software and tracking packages that will allow clinic managers to implement the intervention if it is effective.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Patient-reported medication adherence barriers among patients with cardiovascular risk factors.
    Zullig LL, Stechuchak KM, Goldstein KM, Olsen MK, et al · · 2015 · cited 19× · PMID 26011549 · DOI 10.18553/jmcp.2015.21.6.479
  2. Telemedicine and the assessment of clinician time: a scoping review.
    Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830
  3. Abstracts from the 38th annual meeting of the society of general internal medicine.
    · 2015 · cited 14× · PMID 25869016 · DOI 10.1007/s11606-015-3271-0
  4. Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease.
    Goldstein KM, Stechuchak KM, Zullig LL, Oddone EZ, et al · · 2017 · cited 11× · PMID 28192012 · DOI 10.1089/jwh.2016.5739
  5. Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease.
    Ulmer CS, McCant F, Stechuchak KM, Olsen M, et al · · 2021 · cited 8× · PMID 33688827 · DOI 10.5664/jcsm.9228
  6. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.
    Zullig LL, Oakes MM, McCant F, Bosworth HB. · · 2020 · cited 3× · PMID 32685766 · DOI 10.1016/j.conctc.2020.100612

Verify or expand the search:

Other recruiting trials for Cardiovascular Disease

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01142908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing