NCT01838226

Randomized Controlled Trial of Group Prevention Coaching

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Problem Solving in Cardiovascular Disease in 401 participants. Completed in 30 April 2019.

Timeline

29 August 2014

Primary endpoint
31 October 2018

30 April 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	401
Start date	29 August 2014
Primary completion	31 October 2018
Estimated completion	30 April 2019
Sites	2 locations across United States

Drugs / interventions tested

• Problem Solving

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

21 and older, any sex, with Cardiovascular Disease. 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.

Risk of Fatal Coronary Event or Non-fatal MI Primary · 6 months

The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score. Scores range from 0 - 100, as this is a percentage of risk. Higher scores are worse, as they represent higher risk.

Group	Value	95% CI
Group Prevention Clinics	27.0	± 17.2
Treatment as Usual Control	26.3	± 15.5

Patient Activation Measure Secondary · 6 months

Measure of self-efficacy. Scored from 0-100, with 100 being higher self-efficacy and a better outcome.

Group	Value	95% CI
Group Prevention Clinics	62.1	± 11.5
Treatment as Usual Control	62.6	± 12.2

Risk of Fatal Coronary Event or Non-fatal MI Secondary · 12 month

The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 12 months after enrollment, as measured by Framingham Risk Score. Scores range from 0 - 100, as this is a percentage of risk. Higher scores are worse, as they represent higher risk.

Group	Value	95% CI
Group Prevention Clinics	25.7	± 15.4
Treatment as Usual Control	28.2	± 16.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group Prevention Clinics

Serious: 1/202 (0%)

Deaths: 1/202

Treatment as Usual Control

Serious: 0/199 (0%)

Deaths: 0/199

Serious adverse events (1 terms)

Reaction	System	Group Prevention Clinics	Treatment as Usual Control
death	Cardiac disorders	—	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT01838226 adverse events section.

Sponsor's own description

Prevention of cardiovascular disease is a primary focus of the Secretary's New Models of Care Transformational Initiative. However, prevention has been hard to accomplish. The VA is committed to using group visits to address a wide array of primary care problems. Coaching is a method to help Veterans set and reach health goals by helping them overcome barriers to behavior change. Coaching can be performed one-on-one or in groups. This study will test the effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular risk. GPCs will focus on changing a behavior of the patient's choice that is likely to lead to improvements in heart disease risk. The coach will adopt a problem-solving approach to helping Veterans make these improvements. The primary outcome will be change in 10-year risk of major cardiac event; the investigators will also assess improvements in food choice, physical activity and weight.

Publications & conference data

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

1. Interventions for increasing the use of shared decision making by healthcare professionals.
   Légaré F, Adekpedjou R, Stacey D, Turcotte S, et al · · 2018 · cited 365× · PMID 30025154 · DOI 10.1002/14651858.cd006732.pub4
2. A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.
   Nieuwsma JA, Wray LO, Voils CI, Gierisch JM, et al · · 2017 · cited 4× · PMID 28600161 · DOI 10.1016/j.cct.2017.06.001
3. A data-driven examination of which patients follow trial protocol.
   Olsen MK, Stechuchak KM, Hung A, Oddone EZ, et al · · 2020 · cited 1× · PMID 32913914 · DOI 10.1016/j.conctc.2020.100631