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Prevention Harmful EffectsNCT06730737

Lifewise Preventive Video Education in Primary Care

A study testing Video preventive education in people with Prevention Harmful Effects and Health Maintenance, run by Trinity Health-Livonia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Video preventive education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
1 Apr 2025to 31 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Keyes, MD, MPH contact

734-931-0734

dankeyes@msu.edu

United States1 site, 1 recruiting
  • Trinity Health-Livonia Hospital and Affiliated Clinics

    Livonia, Michigan, 48154

    Laurie McHugh, BS, 734-655-2763, laurie.mchugh@trinity-health.org

    Daniel Keyes, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Brief Lifestyle Medicine Preventive Randomized Prospective Interactive Educational Intervention in the Primary Care Clinic

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.

Read the detailed description

Background and Summary of Objectives: It is widely accepted that prevention is far more impactful than curative medicine concerning overall health efficacy. The primary care setting faces the challenges of increasingly important time constraints and conflicting priorities. However, prevention is a priority regarding the improvement in health outcomes. In a previous pilot study, we investigated the impact of a simple instructional video on patients' willingness to change in the emergency department setting. The initial intervention was passive, requiring subjects to watch a video without interaction. The current study evaluates the practicality and impact of bringing a brief interactive educational video intervention to patients at the primary care clinic visit.

Summary of Study Design This is a randomized, non-blinded prospective study of "just in time" education for adult patients presenting to the primary care clinic immediately following their primary care appointment.

Patients will be randomized to receive the interactive intervention video during this encounter with the practitioner in the clinic. The intervention is an interactive video with a duration of approximately 10-15 minutes. The video is interactive because it asks the patients to answer simple questions about the content in the video to keep them engaged with the content. 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. Before leaving the clinic, all patients will be presented with a questionnaire about their readiness and confidence to initiate lifestyle changes (transtheoretical stage of change measured on a "readiness ruler") and additional survey instruments. Most of these questions will come from existing validated scales, including the Gillespie \& Lenz behavior modification tool, the Pittsburgh Sleep Quality Index, and select questions from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey Patient Satisfaction Survey. They will be asked for access to their medical record and their willingness to be contacted for a follow-up survey.

Outcome measures:

The study's primary outcome will be the results of the Lifestyle Readiness to Change and Confidence to Change questionnaires. Secondary outcomes will include satisfaction with the primary care clinic visit using select questions from HCAHPS, and whether they intend to change any specific lifestyle behavior (dichotomous, yes/no) and, if yes, to specify which one(s), seeking medical care outside of the clinic visit as determined by a review of the patient's medical record at intervals of 30 days and six months. Human immunodeficiency virus (HIV) will not be evaluated outside of its inclusion in the Charlson Comorbidity Index (CCI). A follow-up survey at approximately 3-12 months will evaluate new diagnoses related to chest pain and ask about the individual's lifestyle changes.

Being tested
Video preventive education
Keywords
Prevention, Lifestyle, coronary artery disease, video, video education, video education for adults, preventive health care
Medical subject headings
Feeding Behavior, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video preventive educationBehavioural

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

Study groups in NCT06730737
Study groupRoleWhat they receive
Video intervention groupExperimentalThe 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.
Receives: Behavioral: Video preventive education
ControlNo interventionThis arm consists of those randomized to receive no video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lifestyle Readiness to Change and Confidence to Change questionnaires

    Readiness and confidence to adopt lifestyle changes are assessed using the Gillespie and Lenz Readiness-to-Change and Confidence-to-Change Lifestyle Questionnaires, evaluating 10 lifestyle behaviors. Readiness is measured on a 5-point ordinal scale ranging from 1 (maintaining the behavior for more than 6 months) to 5 (no interest in changing). Confidence is measured on a 3-point ordinal scale ranging from 1 (not very confident) to 3 (very confident). Higher confidence scores indicate greater confidence in adopting the specified lifestyle behavior.

    Measured: At the index primary care visit, immediately after the intervention or corresponding control period.

Secondary outcomes (3)
  1. Patient Satisfaction With Primary Care Visit

    Patient-reported satisfaction with the primary care visit, assessed using selected questions from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

    Measured: At the index primary care visit, immediately following the intervention or corresponding control period.

  2. Intention to Change Lifestyle Behaviors

    Patient-reported intention to make lifestyle changes following the primary care visit. Participants indicate whether they plan to change any lifestyle behaviors (yes/no) and identify specific areas, including diet, exercise, sleep habits, smoking cessation, or other lifestyle modifications.

    Measured: At the index primary care visit, immediately following the intervention or corresponding control period.

  3. Healthcare Utilization Following the Primary Care Visit

    Healthcare utilization following the index primary care visit will be assessed through electronic health record review. The study will evaluate whether participants received additional healthcare services outside the index clinic visit within 30 days and within 6 months. Outcomes will be compared between the intervention and control groups.

    Measured: Within 30 days and 6 months following the index primary care visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start1 Apr 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial of Interactive Preventive Video Education
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730737
Sponsor's protocol ID
TrinityHealthLivonia
Status last verified
Oct 2026
First submitted
8 Dec 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the study's published findings will be made available after study completion, subject to applicable Institutional Review Board requirements, institutional policies, and participant consent provisions. No protected health information or directly identifying participant information will be shared. Copy description

Publications

  • Arroyo DL, Keyes D, Abdulshafi GW, Jafri A, Hasan H, Steinberger D, Dabajeh B, Nassar A, Karn A, Nkrumah R, Dhanoa P, Shedden K. Brief interactive lifestyle preventive medicine video education in the primary care clinic: Protocol for a randomized clinical trial. PLoS One. 2026 Mar 26;21(3):e0322244. doi: 10.1371/journal.pone.0322244. eCollection 2026.

    PubMed 41886477
  • 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.

    PubMed 28359707
  • 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.

    PubMed 10938218
  • 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.

    PubMed 8342192
  • 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.

    PubMed 25193597
  • 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.

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

    PubMed 1620663
  • 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.

    PubMed 34350589
  • 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.

    PubMed 33294604
  • 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.

    PubMed 26590942
  • 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.

    PubMed 18652727
  • 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.

    PubMed 25214177
  • 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.

    PubMed 26526164
  • 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.

    PubMed 32332333
  • 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.

    PubMed 7764850

Questions about this trial

What is this clinical trial studying?

A study testing Video preventive education in people with Prevention Harmful Effects and Health Maintenance, run by Trinity Health-Livonia 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Keyes, MD, MPH (734-931-0734, dankeyes@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lifestyle Readiness to Change and Confidence to Change questionnaires (time frame: At the index primary care visit, immediately after the intervention or corresponding control period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730737, which also lists 19 linked publications.

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 Oct 2026.

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