NCT02971813

Brief Summary

While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular disease (CVD), participation is generally poor. The current feasibility study, will evaluate the impact of a social media intervention on motivation for exercise and adherence to CR sessions. Participants will be randomly assigned to a Facebook™ group or an enhanced education comparison group. The intervention will include access to a private Facebook™ group in which participants will receive weekly educational posts, weekly provider support and have the opportunity to communicate with other cardiac rehabilitation patients. Patients in the comparison group will be given the same educational materials, but these will be supplied in email. Participants will be asked to fill out a pre-post motivational questionnaire and the total number of sessions attended at the end of 3 months will be tallied. This study is grounded in Self-Determination Theory (SDT) and utilizes the Behavioral Regulation in Exercise Questionnaire (BREQ-2), which is based on the SDT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

November 21, 2016

Last Update Submit

March 24, 2020

Conditions

Keywords

cardiac rehabilitationsocial mediaadherencemotivation

Outcome Measures

Primary Outcomes (2)

  • Motivation

    Measured using Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3)

    12 weeks

  • Needs Satisfaction

    Psychological Needs Satisfaction in Exercise Scale (PNSE)

    12 weeks

Secondary Outcomes (1)

  • Adherence

    12 weeks

Study Arms (2)

Facebook group

EXPERIMENTAL

The Facebook group will receive peer support, education and provider support via social media.

Behavioral: Facebook

Comparison group

ACTIVE COMPARATOR

The comparison group will receive the same educational materials as the Facebook™ group but will receive it in handout form, or via email if the patient misses cardiac rehabilitation on a particular week.

Behavioral: Facebook

Interventions

FacebookBEHAVIORAL

1. Volunteers will be recruited during inpatient stay, or via phone call or in person after discharge and prior to beginning cardiac rehabilitation. 2. Participants will be given a baseline BREQ-3 survey and a PNSE scale. 3. Patients will be randomized to Facebook™ versus comparison groups using a blocked randomization. 4. The Facebook™ intervention will include peer support, education, provider support and text message prompts when new posts are added. 1. Educational posts will cover topics that will cover healthcare information. 2. Provider support will be posted much like the educational posts. 5. The data collection for this study will take place prior to beginning cardiac rehabilitation, at which time the participants will receive the BREQ-3 and PNSE surveys either in person or via email link. 6. Post-testing will include a BREQ-3 and PNSE surveys and count of the number of sessions completed in a 3 month period of time.

Comparison groupFacebook group

Eligibility Criteria

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

You may qualify if:

  • All male and female patients who are current and regular Facebook™ users, 18 years of age or older, have qualified for cardiac rehabilitation (diagnosed with cardiovascular disease), and are entering cardiac rehabilitation at the Main Campus of the Cleveland Clinic, will qualify for the study.

You may not qualify if:

  • Participants must be able to exercise to the extent that they can take part in cardiac rehabilitation, must live within 100 miles and must be able to read and speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (40)

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    PMID: 10620381BACKGROUND
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    PMID: 11392867BACKGROUND
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    PMID: 27500157BACKGROUND
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    PMID: 21946418BACKGROUND
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    PMID: 27386722BACKGROUND
  • Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J; ACCFAHA Task Force on Performance Measures. AACVPR/ACCF/AHA 2010 Update: Performance measures on cardiac rehabilitation for referral to cardiac rehabilitation/secondary prevention services: A report of the American Association of Cardiovascular and Pulmonary Rehabilitation and the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Clinical Performance Measures for Cardiac Rehabilitation). J Cardiopulm Rehabil Prev. 2010 Sep-Oct;30(5):279-88. doi: 10.1097/HCR.0b013e3181f5e36f. No abstract available.

    PMID: 20808157BACKGROUND
  • Williams MA, Ades PA, Hamm LF, Keteyian SJ, LaFontaine TP, Roitman JL, Squires RW. Clinical evidence for a health benefit from cardiac rehabilitation: an update. Am Heart J. 2006 Nov;152(5):835-41. doi: 10.1016/j.ahj.2006.05.015.

    PMID: 17070142BACKGROUND
  • Deci EL, Ryan RM. Intrinsic Motivation and Self-determination in Human Behavior. New York, NY: Plenum Press. 1985. ISBN: 978-1-4899-2273-1.

    BACKGROUND
  • deCharms R. Personal Causation. New York, NY: Academic Press. 1968. ISBN 13: 9780122085505.

    BACKGROUND
  • Balatsoukas P, Kennedy CM, Buchan I, Powell J, Ainsworth J. The Role of Social Network Technologies in Online Health Promotion: A Narrative Review of Theoretical and Empirical Factors Influencing Intervention Effectiveness. J Med Internet Res. 2015 Jun 11;17(6):e141. doi: 10.2196/jmir.3662.

  • Cadmus-Bertram L, Irwin M, Alfano C, Campbell K, Duggan C, Foster-Schubert K, Wang CY, McTiernan A. Predicting adherence of adults to a 12-month exercise intervention. J Phys Act Health. 2014 Sep;11(7):1304-12. doi: 10.1123/jpah.2012-0258. Epub 2013 Oct 31.

  • Cavallo DN, Tate DF, Ries AV, Brown JD, DeVellis RF, Ammerman AS. A social media-based physical activity intervention: a randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):527-32. doi: 10.1016/j.amepre.2012.07.019.

  • Cavallo DN, Tate DF, Ward DS, DeVellis RF, Thayer LM, Ammerman AS. Social support for physical activity-role of Facebook with and without structured intervention. Transl Behav Med. 2014 Dec;4(4):346-54. doi: 10.1007/s13142-014-0269-9.

  • Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.

  • Devi R, Powell J, Singh S. A web-based program improves physical activity outcomes in a primary care angina population: randomized controlled trial. J Med Internet Res. 2014 Sep 12;16(9):e186. doi: 10.2196/jmir.3340.

  • Ghashghaei FE, Sadeghi M, Marandi SM, Ghashghaei SE. Exercise-based cardiac rehabilitation improves hemodynamic responses after coronary artery bypass graft surgery. ARYA Atheroscler. 2012 Winter;7(4):151-6.

  • Irwin B, Kurz D, Chalin P, Thompson N. Testing the Efficacy of OurSpace, a Brief, Group Dynamics-Based Physical Activity Intervention: A Randomized Controlled Trial. J Med Internet Res. 2016 May 6;18(4):e87. doi: 10.2196/jmir.5342.

  • Joseph RP, Keller C, Adams MA, Ainsworth BE. Print versus a culturally-relevant Facebook and text message delivered intervention to promote physical activity in African American women: a randomized pilot trial. BMC Womens Health. 2015 Mar 27;15:30. doi: 10.1186/s12905-015-0186-1.

  • Karmali KN, Davies P, Taylor F, Beswick A, Martin N, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2014 Jun 25;(6):CD007131. doi: 10.1002/14651858.CD007131.pub3.

  • Magnezi R, Bergman YS, Grosberg D. Online activity and participation in treatment affects the perceived efficacy of social health networks among patients with chronic illness. J Med Internet Res. 2014 Jan 10;16(1):e12. doi: 10.2196/jmir.2630.

  • Maher C, Ferguson M, Vandelanotte C, Plotnikoff R, De Bourdeaudhuij I, Thomas S, Nelson-Field K, Olds T. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 13;17(7):e174. doi: 10.2196/jmir.4086.

  • Martin BJ, Hauer T, Arena R, Austford LD, Galbraith PD, Lewin AM, Knudtson ML, Ghali WA, Stone JA, Aggarwal SG. Cardiac rehabilitation attendance and outcomes in coronary artery disease patients. Circulation. 2012 Aug 7;126(6):677-87. doi: 10.1161/CIRCULATIONAHA.111.066738. Epub 2012 Jul 9.

  • Napolitano MA, Hayes S, Bennett GG, Ives AK, Foster GD. Using Facebook and text messaging to deliver a weight loss program to college students. Obesity (Silver Spring). 2013 Jan;21(1):25-31. doi: 10.1002/oby.20232.

  • Ribeiro F, Oliveira NL, Silva G, Campos L, Miranda F, Teixeira M, Alves AJ, Oliveira J. Exercise-based cardiac rehabilitation increases daily physical activity of patients following myocardial infarction: subanalysis of two randomised controlled trials. Physiotherapy. 2017 Mar;103(1):59-65. doi: 10.1016/j.physio.2015.12.002. Epub 2015 Dec 25.

  • Struik LL, Baskerville NB. The role of Facebook in Crush the Crave, a mobile- and social media-based smoking cessation intervention: qualitative framework analysis of posts. J Med Internet Res. 2014 Jul 11;16(7):e170. doi: 10.2196/jmir.3189.

  • Valle CG, Tate DF, Mayer DK, Allicock M, Cai J. A randomized trial of a Facebook-based physical activity intervention for young adult cancer survivors. J Cancer Surviv. 2013 Sep;7(3):355-68. doi: 10.1007/s11764-013-0279-5. Epub 2013 Mar 27.

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  • Haakma I, Janssen M, Minnaert A. Understanding the Relationship Between Teacher Behavior and Motivation in Students with Acquired Deafblindness. Am Ann Deaf. 2016 Summer;161(3):314-26. doi: 10.1353/aad.2016.0024.

  • Siegmund LA, Naylor J, Bena J, McClelland M. The relationship between Metabolic Syndrome and adherence to cardiac rehabilitation. Physiol Behav. 2017 Feb 1;169:41-45. doi: 10.1016/j.physbeh.2016.11.005. Epub 2016 Nov 11. No abstract available.

  • Rawstorn JC, Gant N, Meads A, Warren I, Maddison R. Remotely Delivered Exercise-Based Cardiac Rehabilitation: Design and Content Development of a Novel mHealth Platform. JMIR Mhealth Uhealth. 2016 Jun 24;4(2):e57. doi: 10.2196/mhealth.5501.

  • Wilson PM, Rodgers WM, Loitz CC, Scime, G. "It's who I am…really!" The importance of integrated regulation in exercise contexts. Journal of Biobehavioral Research. 2006; 11(2), 79-104.

    RESULT
  • Lindwall M, Ivarsson A, Weman-Josefsson K, Jonsson L, Ntoumanis N, Patrick H, Thogersen-Ntoumani C, Markland D, Teixeira P. Stirring the motivational soup: within-person latent profiles of motivation in exercise. Int J Behav Nutr Phys Act. 2017 Jan 14;14(1):4. doi: 10.1186/s12966-017-0464-4.

  • Thorup CB, Gronkjaer M, Spindler H, Andreasen JJ, Hansen J, Dinesen BI, Nielsen G, Sorensen EE. Pedometer use and self-determined motivation for walking in a cardiac telerehabilitation program: a qualitative study. BMC Sports Sci Med Rehabil. 2016 Aug 18;8:24. doi: 10.1186/s13102-016-0048-7. eCollection 2016.

  • Wilson P, Rogers WT, Rodgers WM. The Psychological Need Satisfaction in Exercise Scale. J Sport Exerc Psychol. 2006; 28, 231-51.

    RESULT
  • Markland D, Tobin V. A modification of the Behavioral Regulation in Exercise Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology. 2004; 26(2), 191-96. doi: 10.1123/jsep.26.2.191.

    RESULT
  • Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.

  • Siegmund LA, Bena JF, Morrison SL. Cardiac Rehabilitation Facebook Intervention: Feasibility Randomized Controlled Trial. JMIR Cardio. 2023 Jun 15;7:e46828. doi: 10.2196/46828.

  • Siegmund LA, Ahmed HM, Crawford MT, Bena JF. Feasibility of a Facebook Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: Study Protocol. JMIR Res Protoc. 2017 Aug 18;6(8):e162. doi: 10.2196/resprot.7554.

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Lee A Siegmund, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Scientist

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

February 27, 2017

Primary Completion

February 28, 2019

Study Completion

March 1, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Facebook log in's and demographic variables as well as survey responses will be shared with the research team. This information will be shared using encrypted flash drives and computers and emails will be confidential. All responses from participants on the Facebook™ group will be assigned a number and all other identifying information will be removed for data analysis. Any data on paper will be kept in the PI's locked office in a locked filing cabinet. All electronic data will be stored on the PI's computer which requires password entry and in a folder accessible only to the PI and the research team.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 2/27/17 until after manuscript submission
Access Criteria
With permission of PI

Locations