NCT06730737

Brief Summary

It is widely accepted that prevention is far more impactful than curative medicine and must be included in primary care. In a previous pilot study, we evaluated passive video preventive lifestyle education in the emergency department. The current study is a randomized prospective trial assessing the practicality and impact of a brief interactive educational video intervention to patients during primary care clinic visits.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

December 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 8, 2024

Last Update Submit

December 8, 2024

Conditions

Keywords

PreventionLifestylecoronary artery diseasevideovideo educationvideo education for adultspreventive health care

Outcome Measures

Primary Outcomes (1)

  • Lifestyle Readiness to Change and Confidence to Change questionnaires

    The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires.

    Immediately following exposure to the intervention or not (both arms receive the questionnaires)

Secondary Outcomes (1)

  • Satisfaction, intent to changve lifestyle behavior, follow up clinic visit

    18 months

Study Arms (2)

Video intervention group

EXPERIMENTAL

The intervention is an interactive preventive education video lasting approximately 10 minutes. The video is interactive because it asks the patients to answer simple questions about the content in the video to keep them engaged. For instance, if the participant indicates that they do not smoke, the video will "skip" the smoking cessation education and move directly to the other prevention domains.

Other: Video preventive education

Control

NO INTERVENTION

This arm consists of those randomized to receive no video

Interventions

Interactive video that teaches the subject about the overall importance of prevention, smoking cessation, proper diet, exercise, and sleep.

Video intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 18 and 80, inclusive.

You may not qualify if:

  • Non-English-speaking patient
  • Unable or unwilling to consent to the study
  • Unable or unwilling to hear a video on a smartphone or computer tablet
  • The patient is in hospice care
  • Patients with advanced dementia, in the opinion of the person administering the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinity Health-Livonia Hospital and Affiliated Clinics

Livonia, Michigan, 48154, United States

Location

Related Publications (18)

  • Wood EB, Harrison G, Trickey A, Friesen MA, Stinson S, Rovelli E, McReynolds S, Presgrave K. Evidence-Based Practice: Video-Discharge Instructions in the Pediatric Emergency Department. J Emerg Nurs. 2017 Jul;43(4):316-321. doi: 10.1016/j.jen.2016.11.003. Epub 2017 Mar 28.

    PMID: 28359707BACKGROUND
  • Stange KC, Flocke SA, Goodwin MA, Kelly RB, Zyzanski SJ. Direct observation of rates of preventive service delivery in community family practice. Prev Med. 2000 Aug;31(2 Pt 1):167-76. doi: 10.1006/pmed.2000.0700.

    PMID: 10938218BACKGROUND
  • Schuling J, de Haan R, Limburg M, Groenier KH. The Frenchay Activities Index. Assessment of functional status in stroke patients. Stroke. 1993 Aug;24(8):1173-7. doi: 10.1161/01.str.24.8.1173.

    PMID: 8342192BACKGROUND
  • Rising KL, Padrez KA, O'Brien M, Hollander JE, Carr BG, Shea JA. Return visits to the emergency department: the patient perspective. Ann Emerg Med. 2015 Apr;65(4):377-386.e3. doi: 10.1016/j.annemergmed.2014.07.015. Epub 2014 Aug 27.

    PMID: 25193597BACKGROUND
  • Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

    PMID: 10170434BACKGROUND
  • Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif. 1992;28:183-218. No abstract available.

    PMID: 1620663BACKGROUND
  • Pickens GT, Moore B, Smith MW, McDermott KW, Mummert A, Karaca Z. Methods for estimating the cost of treat-and-release emergency department visits. Health Serv Res. 2021 Oct;56(5):953-961. doi: 10.1111/1475-6773.13709. Epub 2021 Aug 5.

    PMID: 34350589BACKGROUND
  • Pathak S, Summerville G, Kaplan CP, Nouri SS, Karliner LS. Patient-Reported Use of the After Visit Summary in a Primary Care Internal Medicine Practice. J Patient Exp. 2020 Oct;7(5):703-707. doi: 10.1177/2374373519879286. Epub 2019 Oct 4.

    PMID: 33294604BACKGROUND
  • Park H, Roubal AM, Jovaag A, Gennuso KP, Catlin BB. Relative Contributions of a Set of Health Factors to Selected Health Outcomes. Am J Prev Med. 2015 Dec;49(6):961-9. doi: 10.1016/j.amepre.2015.07.016.

    PMID: 26590942BACKGROUND
  • Papa L, Seaberg DC, Rees E, Ferguson K, Stair R, Goldfeder B, Meurer D. Does a waiting room video about what to expect during an emergency department visit improve patient satisfaction? CJEM. 2008 Jul;10(4):347-54. doi: 10.1017/s1481803500010356.

    PMID: 18652727BACKGROUND
  • McCarthy DM, Engel KG, Buckley BA, Huang A, Acosta F, Stancati J, Schmidt MJ, Adams JG, Cameron KA. Talk-time in the emergency department: duration of patient-provider conversations during an emergency department visit. J Emerg Med. 2014 Nov;47(5):513-9. doi: 10.1016/j.jemermed.2014.06.056. Epub 2014 Sep 8.

    PMID: 25214177BACKGROUND
  • Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health Rankings: Relationships Between Determinant Factors and Health Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. doi: 10.1016/j.amepre.2015.08.024. Epub 2015 Oct 31.

    PMID: 26526164BACKGROUND
  • Hirabayashi KJ, Pomerantz M, Radell JE, Chadha N, Thomas S, Serle JB. The Efficacy of the After-visit Summary in Medication Recall Among Glaucoma Patients. J Glaucoma. 2020 Jul;29(7):529-535. doi: 10.1097/IJG.0000000000001518.

    PMID: 32332333BACKGROUND
  • Goodacre R, Karim A, Kaderbhai MA, Kell DB. Rapid and quantitative analysis of recombinant protein expression using pyrolysis mass spectrometry and artificial neural networks: application to mammalian cytochrome b5 in Escherichia coli. J Biotechnol. 1994 May 15;34(2):185-93. doi: 10.1016/0168-1656(94)90088-4.

    PMID: 7764850BACKGROUND
  • Colby SM, Monti PM, O'Leary Tevyaw T, Barnett NP, Spirito A, Rohsenow DJ, Riggs S, Lewander W. Brief motivational intervention for adolescent smokers in medical settings. Addict Behav. 2005 Jun;30(5):865-74. doi: 10.1016/j.addbeh.2004.10.001. Epub 2004 Nov 10.

    PMID: 15893085BACKGROUND
  • Dhawan N, Saeed O, Gupta V, Desai R, Ku M, Bhoi S, Verma S. Utilizing video on myocardial infarction as a health educational intervention in patient waiting areas of the developing world: A study at the emergency department of a major tertiary care hospital in India. Int Arch Med. 2008 Jul 29;1(1):14. doi: 10.1186/1755-7682-1-14.

    PMID: 18662408BACKGROUND
  • Ding R, McCarthy ML, Desmond JS, Lee JS, Aronsky D, Zeger SL. Characterizing waiting room time, treatment time, and boarding time in the emergency department using quantile regression. Acad Emerg Med. 2010 Aug;17(8):813-23. doi: 10.1111/j.1553-2712.2010.00812.x.

    PMID: 20670318BACKGROUND
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorCoronary Artery Disease

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Daniel Keyes, MD, MPH

    Trinity Health-Livonia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Keyes, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial of Interactive Preventive Video Education
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chair, Academic Affairs, Principal Investigator

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 12, 2024

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The data contains patient health information (PHI), and currently, there is no plan for public disclosure of the data.

Locations