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A Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Lee Anne Siegmund, The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Lee Anne Siegmund, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02971813
First received: November 21, 2016
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
While cardiac rehabilitation (CR) has been shown to be effective at improving cardiovascular disease (CVD), participation is generally poor. For this reason, the current research, a prospective, randomized controlled pilot 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 handout form, or email if the patient is absent from cardiac rehabilitation. 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.

Condition Intervention
Cardiovascular Diseases Behavioral: Facebook

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of a Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence

Resource links provided by NLM:


Further study details as provided by Lee Anne Siegmund, The Cleveland Clinic:

Primary Outcome Measures:
  • Motivation [ Time Frame: 12 weeks ]
    Measured using Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3)

  • Needs Satisfaction [ Time Frame: 12 weeks ]
    Psychological Needs Satisfaction in Exercise Scale (PNSE)


Secondary Outcome Measures:
  • Adherence [ Time Frame: 12 weeks ]
    Number of cardiac rehabilitation sessions attended


Estimated Enrollment: 60
Actual Study Start Date: February 27, 2017
Estimated Study Completion Date: April 27, 2018
Estimated Primary Completion Date: February 27, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Facebook group
The Facebook group will receive peer support, education and provider support via social media.
Behavioral: Facebook
  1. Volunteers will be recruited at their intake visit or prior to intake to phase II during inpatient stay.
  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 during the entrance visit for CR or prior to intake while inpatient, at which time the participants will receive the BREQ-3 and PNSE surveys
  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.
Active Comparator: Comparison group
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
  1. Volunteers will be recruited at their intake visit or prior to intake to phase II during inpatient stay.
  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 during the entrance visit for CR or prior to intake while inpatient, at which time the participants will receive the BREQ-3 and PNSE surveys
  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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02971813

Contacts
Contact: Nancy Albert, PhD, RN 216-444-7028 albertn@ccf.org

Locations
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nancy Albert, PhD, RN    216-444-7028    albertn@ccf.org   
Principal Investigator: Lee Anne Siegmund, PhD, RN         
Sub-Investigator: Haitham Ahmed, MD         
Sub-Investigator: Michael Crawford, PhD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Lee A Siegmund, PhD The Cleveland Clinic
  More Information

Additional Information:
Publications:
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.
Wilson P, Rogers WT, Rodgers WM. The Psychological Need Satisfaction in Exercise Scale. J Sport Exerc Psychol. 2006; 28, 231-51.
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.
Deci EL, Ryan RM. Intrinsic Motivation and Self-determination in Human Behavior. New York, NY: Plenum Press. 1985. ISBN: 978-1-4899-2273-1.
deCharms R. Personal Causation. New York, NY: Academic Press. 1968. ISBN 13: 9780122085505.

Responsible Party: Lee Anne Siegmund, Nurse Researcher, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02971813     History of Changes
Other Study ID Numbers: 16-1456
Study First Received: November 21, 2016
Last Updated: July 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lee Anne Siegmund, The Cleveland Clinic:
cardiac rehabilitation
social media
adherence
motivation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 23, 2017