Cardiovascular DiseasesNCT02971813
A Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence
A study testing Facebook in people with Cardiovascular Diseases, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence
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.
Read the detailed description
There is no research that addresses the use of Facebook as a tool to affect autonomous motivation in cardiac rehabilitation.
The purpose of the current feasibility study is to determine the feasibility of using a Facebook intervention, providing education, peer support and provider support, to affect change in motivation and self-determination for exercise, and adherence to cardiac rehabilitation in patients with CHD during a 12-week Phase II cardiac rehabilitation program. It is hypothesized that:
- Scores for motivation for exercise overall will increase for patients exposed to a Facebook intervention and across individual motivational subtypes (regulations) relative to a comparison group who receive educational handouts and emails.
- Percentage of cardiac rehabilitation sessions attended will be higher relative to a comparison group who receive educational handouts and emails.
- Engagement in the private Facebook group (number of "hits" and "likes") will predict number of cardiac rehabilitation sessions attended and the change in motivation. The feasibility of a larger trial will be based on sample size and participants' engagement in the Facebook group.
Methodology Design This is a prospective, randomized controlled pilot trial to evaluate the feasibility of using a social media intervention to affect change in motivation for exercise and adherence to cardiac rehabilitation.
Setting and Sample:
The setting for this study will be in the outpatient cardiac rehabilitation at the main campus of a large tertiary care center in Northeast Ohio and several satellite facilities in the region. All patients receive an individualized exercise prescription based on functional capacity at intake. Most patients will be able to attend up to 3 sessions per week for a total of 36 sessions.
All patients who are current and regular Facebook users, have qualified for cardiac rehabilitation (diagnosed with CHD), and are entering cardiac rehabilitation at the main campus or one of the regional satellite hospitals of this tertiary care center, will qualify to participate in the study prior to beginning Phase II cardiac rehabilitation. Current Facebook users were chosen . Regular use will be defined as logging onto Facebook at least 2 times in the last month. Inclusion criteria will include both men and women 18 years of age or older and live within 100 miles of the main campus of this tertiary care center. Participants must be able to read and understand English in order to complete the questionnaires: the Psychological Need Satisfaction in Exercise Scale (PNSE) [37] and the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). There will be no exclusion based on secondary diagnosis; however, participants must be able to exercise well enough to qualify to take part in cardiac rehabilitation.
Measures:
Change in motivation for exercise, will be measured at baseline and post-intervention using the BREQ-3. The BREQ-3 is a 24 question validated instrument that measures forms of intrinsic and extrinsic regulation of exercise behavior and is based on self-determination theory. Psychometrics were completed for the BREQ-2 by Markland and Tobin. Cronbach's alpha reliabilities were: amotivation = 0.83, external regulation = 0.79, introjected regulation = 0.80, identified regulation = 0.73, and intrinsic regulation = 0.86. The BREQ-3 includes 5 additional questions in addition to those on the BREQ-2 and has a new subscale for integrated regulation [33]. The subscales (regulations) of the BREQ-3 are used to calculate a relative autonomy index (RAI). Each question is answered on a 5 point Likert scale (0-4) and represents one of the regulations. The regulations are weighted then summed to give a single score. The resulting index gives an indication of individual respondent's self-determination for exercise.
The RAI will place individual motivational subtypes or behavioral regulations on the self-determination continuum from amotivated (lacking intention to exercise) to intrinsically motivated (self-determined or autonomously motivated).
The PNSE will be used to assess need satisfaction with exercise. This scale was designed to assess the perception of psychological need satisfaction associated with self-determined motivation for exercise and consists of 18 items on a 6 point Likert scale, with 3 subscales measuring perceived competence, autonomy, and relatedness. The scale showed high internal consistency (Cronbach >0.90) [37].
The percentage of cardiac rehabilitation sessions attended will be measured at the time of cardiac rehabilitation completion or dropout. It will calculated by dividing the number of sessions attended in a 3 month period of time by the total number of sessions allowed by insurance, and multiplying by 100.
Facebook engagement, will be assessed by measuring the number of "likes" by individuals on the private Facebook group. "Likes" (the number of times a participant clicks "like" on any of the Facebook posts) will be counted and, along with "hits" will be used to examine the association between engagement in the intervention, and cardiac rehabilitation adherence and change in motivation. A post-intervention questionnaire will be given to determine number of "hits". The participants will be asked to circle the number of times they accessed the private Facebook group per week: 0, 1-5, 6-10, 11-15 or > 15 times. The questionnaire will also be used to collect qualitative data on participants' perceptions of the intervention, including whether they felt supported in their care, more in touch with providers, whether or not they chatted with other Facebook members and if the Facebook group affected their exercise behaviors. The questionnaire will use a Likert scale (1, "not at all"-5, "quite a bit") for all questions and a section for comments.
Patient characteristics will include key demographic variables (age, gender, race, employment, distance to cardiac rehabilitation, socioeconomic status), engagement (number of "hits" and "likes"), and key clinical variables (functional capacity as measured in METS,cardiac rehabilitation indication, hypertension, diabetes, hyperlipidemia and waist circumference), which will be obtained from the electronic medical record.
Data Collection Procedures:
Volunteers will be recruited from the main campus or regional satellite hospitals of this tertiary care center during their inpatient stay, at the intake visit for cardiac rehabilitation at the main campus and satellite facilities in the region, or via phone call after discharge and up to the first cardiac rehabilitation session. Volunteers will be screened for Facebook use and interest in the study, then an email link will be sent which will include an information sheet. The Facebook group will be private in the sense that those not in the group will not be able to see the content. Participants will be given a baseline BREQ-3 questionnaire and PNSE scale. Participants will then be randomized to Facebook versus comparison groups using blocked randomization.
Intervention. The Facebook intervention will include peer support, education, provider support. These interventions are designed to minimize pressure, offer choices, and allow for peer interaction, and positive feedback in order to provide support for competence, autonomy and relatedness. Competence will be supported with use of educational posts. Autonomy support will come from provider posts. Relatedness will be supported by peer interaction and engagement in the Facebook group.
Educational posts will cover topics that will encourage participants to practice preventive heart care. The educational portion of the intervention is designed to offer clear information and structure, thus supporting competence. The posts may be in the form of text, video and/or pictures and will include materials from the hospital's health library, the American Heart Association and the Center for Disease Control.
Provider posts will include topics such as motivational quotes, encouragement, reminders to exercise independently, and reminders to contact providers with questions. These postings are designed to promote a sense of choice and help participants feel that providers see them as having a unique frame of reference thus being autonomy-supportive. Providers will be nurses on the research team, exercise physiologists nurse practitioners and physicians. Provider support will also include links to provider health chats, in which patients can chat online with providers at set dates and times.
Peer interaction on Facebook will be as frequently as the participant chooses and will be monitored daily by the research team. Engagement in Facebook is designed to offer an opportunity for social inclusion and a sense of involvement.
The comparison group will receive the same educational and provider support materials as the Facebook group but will receive it via email. Both groups will have the opportunity for weekly education classes and typical peer interactions.
Upon cardiac rehabilitation completion or dropout, post-data will be collected. It is anticipated that this pilot will take up to one year and will be completed when 30 participants for each group have been obtained.
Data Analysis Statistical Methods. This is a feasibility study and the sample size obtained will determine if the study is appropriately powered to detect the desired effect size. Patient characteristics will be summarized group using frequencies and percentages for categorical factors, and means and standard deviations for continuous measures. In order to examine the primary outcome, differences in change in motivation between groups, overall motivation using the RAI from the BREQ-3 will be evaluated using analysis of covariance (ANCOVA) models. Mean differences with 95% confidence intervals for group differences will be presented. Multivariate analysis of variance models will be used to evaluate differences in the change across individual motivation subtypes (regulations), using the BREQ-3, between groups overall. If significant, separate ANCOVA models for each subtype will be fit. Similar models will be used to compare changes in needs satisfaction scores, overall and separately among the three subscales, between groups. Two-sample t-tests will be used to compare number of sessions completed. As a secondary analysis, the relationships between patient characteristics, "hits" and "likes", and the outcome variables RAI change, number of sessions, and needs satisfaction change will be examined using t-tests and Pearson correlations. The correlation between changes in RAI and needs satisfaction will also be evaluated. Analyses will be performed using SAS software (version 9.4; Cary, NC). An overall significance level of 0.05 will be assumed for all tests.
Sample Size. The investigators plan to enroll 30 patients in each group. In the first 9 months of 2016, cardiac rehabilitation at the main campus of this tertiary care center had approximately 170 patient intakes. It is assumed that there will be a similar number of patient intakes for a 9 month period in 2017. Based on Facebook participation rates for those over age 50 [21] and the high participation rates in previous research projects in this facility's cardiac rehabilitation, it is estimated that 40% may meet eligibility requirements and agree to participate. Allowing for use of the first 8 participants to establish the Facebook group, the estimated sample size would then be 60 total participants for randomization to study group who can then be included in analysis. With this sample size, there will be 86% power to detect large effect sizes (d=0.8) for our study outcomes [40]. The primary aim of this sample size determination is to evaluate whether the proposed intervention is feasible, and to estimate the differences that might exist so that a larger trial that would have adequate power to detect smaller differences could be designed based on what was learned in this pilot study. The sample size of 30 per group was chosen primarily to facilitate a large intervention group, since the value of the intervention is predicated upon interaction among the participants.
- Conditions
- Cardiovascular Diseases
- Being tested
- Keywords
- cardiac rehabilitation, social media, adherence, motivation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FacebookBehavioural
- Volunteers will be recruited during inpatient stay, or via phone call or in person after discharge and prior to beginning cardiac rehabilitation.
- Participants will be given a baseline BREQ-3 survey and a PNSE scale.
- Patients will be randomized to Facebook™ versus comparison groups using a blocked randomization.
- The Facebook™ intervention will include peer support, education, provider support and text message prompts when new posts are added.
- Educational posts will cover topics that will cover healthcare information.
- Provider support will be posted much like the educational posts.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Facebook group | Experimental | The Facebook group will receive peer support, education and provider support via social media. Receives: 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. Receives: Behavioral: Facebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation
Measured using Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3)
Measured: 12 weeks
Needs Satisfaction
Psychological Needs Satisfaction in Exercise Scale (PNSE)
Measured: 12 weeks
Secondary outcomes (1)
Adherence
Number of cardiac rehabilitation sessions attended
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start27 Feb 2017
- Primary completion28 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing
- Responsible party
- Principal investigator, Lee Anne Siegmund, The Cleveland Clinic
- Investigators
- Lee A Siegmund, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971813
- Sponsor's protocol ID
- 16-1456
- Status last verified
- Mar 2020
- First submitted
- 21 Nov 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Coyan GN, Reeder KM, Vacek JL, Coyan GN, Reeder KM, Vacek JL. Diet and exercise interventions following coronary artery bypass graft surgery: a review and call to action. Phys Sportsmed. 2014 May;42(2):119-29. doi: 10.3810/psm.2014.05.2064.
PubMed 24875979Deci EL, Ryan RM. The support of autonomy and the control of behavior. J Pers Soc Psychol. 1987 Dec;53(6):1024-37. doi: 10.1037//0022-3514.53.6.1024.
PubMed 3320334Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.
PubMed 10620381Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
PubMed 11392867Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33.
PubMed 27500157Savage PD, Sanderson BK, Brown TM, Berra K, Ades PA. Clinical research in cardiac rehabilitation and secondary prevention: looking back and moving forward. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):333-41. doi: 10.1097/HCR.0b013e31822f0f79.
PubMed 21946418Servey JT, Stephens M. Cardiac Rehabilitation: Improving Function and Reducing Risk. Am Fam Physician. 2016 Jul 1;94(1):37-43.
PubMed 27386722Thomas 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.
PubMed 20808157Williams 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.
PubMed 17070142Deci 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.
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.
PubMed 26068087Cadmus-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.
PubMed 24176780Cavallo 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.
PubMed 23079176Cavallo 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.
PubMed 25584083
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Social Media Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence
- ClinicalTrials.gov ID
- NCT02971813
- Acronym / sponsor ID
- 16-1456
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiac rehabilitation, social media, adherence, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is no research that addresses the use of Facebook as a tool to affect autonomous motivation in cardiac rehabilitation.
The purpose of the current feasibility study is to determine the feasibility of using a Facebook intervention, providing education, peer support and provider support, to affect change in motivation and self-determination for exercise, and adherence to cardiac rehabilitation in patients with CHD during a 12-week Phase II cardiac rehabilitation program. It is hypothesized that:
- Scores for motivation for exercise overall will increase for patients exposed to a Facebook intervention and across individual motivational subtypes (regulations) relative to a comparison group who receive educational handouts and emails.
- Percentage of cardiac rehabilitation sessions attended will be higher relative to a comparison group who receive educational handouts and emails.
- Engagement in the private Facebook group (number of "hits" and "likes") will predict number of cardiac rehabilitation sessions attended and the change in motivation. The feasibility of a larger trial will be based on sample size and participants' engagement in the Facebook group.
Methodology Design This is a prospective, randomized controlled pilot trial to evaluate the feasibility of using a social media intervention to affect change in motivation for exercise and adherence to cardiac rehabilitation.
Setting and Sample:
The setting for this study will be in the outpatient cardiac rehabilitation at the main campus of a large tertiary care center in Northeast Ohio and several satellite facilities in the region. All patients receive an individualized exercise prescription based on functional capacity at intake. Most patients will be able to attend up to 3 sessions per week for a total of 36 sessions.
All patients who are current and regular Facebook users, have qualified for cardiac rehabilitation (diagnosed with CHD), and are entering cardiac rehabilitation at the main campus or one of the regional satellite hospitals of this tertiary care center, will qualify to participate in the study prior to beginning Phase II cardiac rehabilitation. Current Facebook users were chosen . Regular use will be defined as logging onto Facebook at least 2 times in the last month. Inclusion criteria will include both men and women 18 years of age or older and live within 100 miles of the main campus of this tertiary care center. Participants must be able to read and understand English in order to complete the questionnaires: the Psychological Need Satisfaction in Exercise Scale (PNSE) [37] and the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). There will be no exclusion based on secondary diagnosis; however, participants must be able to exercise well enough to qualify to take part in cardiac rehabilitation.
Measures:
Change in motivation for exercise, will be measured at baseline and post-intervention using the BREQ-3. The BREQ-3 is a 24 question validated instrument that measures forms of intrinsic and extrinsic regulation of exercise behavior and is based on self-determination theory. Psychometrics were completed for the BREQ-2 by Markland and Tobin. Cronbach's alpha reliabilities were: amotivation = 0.83, external regulation = 0.79, introjected regulation = 0.80, identified regulation = 0.73, and intrinsic regulation = 0.86. The BREQ-3 includes 5 additional questions in addition to those on the BREQ-2 and has a new subscale for integrated regulation [33]. The subscales (regulations) of the BREQ-3 are used to calculate a relative autonomy index (RAI). Each question is answered on a 5 point Likert scale (0-4) and represents one of the regulations. The regulations are weighted then summed to give a single score. The resulting index gives an indication of individual respondent's self-determination for exercise.
The RAI will place individual motivational subtypes or behavioral regulations on the self-determination continuum from amotivated (lacking intention to exercise) to intrinsically motivated (self-determined or autonomously motivated).
The PNSE will be used to assess need satisfaction with exercise. This scale was designed to assess the perception of psychological need satisfaction associated with self-determined motivation for exercise and consists of 18 items on a 6 point Likert scale, with 3 subscales measuring perceived competence, autonomy, and relatedness. The scale showed high internal consistency (Cronbach >0.90) [37].
The percentage of cardiac rehabilitation sessions attended will be measured at the time of cardiac rehabilitation completion or dropout. It will calculated by dividing the number of sessions attended in a 3 month period of time by the total number of sessions allowed by insurance, and multiplying by 100.
Facebook engagement, will be assessed by measuring the number of "likes" by individuals on the private Facebook group. "Likes" (the number of times a participant clicks "like" on any of the Facebook posts) will be counted and, along with "hits" will be used to examine the association between engagement in the intervention, and cardiac rehabilitation adherence and change in motivation. A post-intervention questionnaire will be given to determine number of "hits". The participants will be asked to circle the number of times they accessed the private Facebook group per week: 0, 1-5, 6-10, 11-15 or > 15 times. The questionnaire will also be used to collect qualitative data on participants' perceptions of the intervention, including whether they felt supported in their care, more in touch with providers, whether or not they chatted with other Facebook members and if the Facebook group affected their exercise behaviors. The questionnaire will use a Likert scale (1, "not at all"-5, "quite a bit") for all questions and a section for comments.
Patient characteristics will include key demographic variables (age, gender, race, employment, distance to cardiac rehabilitation, socioeconomic status), engagement (number of "hits" and "likes"), and key clinical variables (functional capacity as measured in METS,cardiac rehabilitation indication, hypertension, diabetes, hyperlipidemia and waist circumference), which will be obtained from the electronic medical record.
Data Collection Procedures:
Volunteers will be recruited from the main campus or regional satellite hospitals of this tertiary care center during their inpatient stay, at the intake visit for cardiac rehabilitation at the main campus and satellite facilities in the region, or via phone call after discharge and up to the first cardiac rehabilitation session. Volunteers will be screened for Facebook use and interest in the study, then an email link will be sent which will include an information sheet. The Facebook group will be private in the sense that those not in the group will not be able to see the content. Participants will be given a baseline BREQ-3 questionnaire and PNSE scale. Participants will then be randomized to Facebook versus comparison groups using blocked randomization.
Intervention. The Facebook intervention will include peer support, education, provider support. These interventions are designed to minimize pressure, offer choices, and allow for peer interaction, and positive feedback in order to provide support for competence, autonomy and relatedness. Competence will be supported with use of educational posts. Autonomy support will come from provider posts. Relatedness will be supported by peer interaction and engagement in the Facebook group.
Educational posts will cover topics that will encourage participants to practice preventive heart care. The educational portion of the intervention is designed to offer clear information and structure, thus supporting competence. The posts may be in the form of text, video and/or pictures and will include materials from the hospital's health library, the American Heart Association and the Center for Disease Control.
Provider posts will include topics such as motivational quotes, encouragement, reminders to exercise independently, and reminders to contact providers with questions. These postings are designed to promote a sense of choice and help participants feel that providers see them as having a unique frame of reference thus being autonomy-supportive. Providers will be nurses on the research team, exercise physiologists nurse practitioners and physicians. Provider support will also include links to provider health chats, in which patients can chat online with providers at set dates and times.
Peer interaction on Facebook will be as frequently as the participant chooses and will be monitored daily by the research team. Engagement in Facebook is designed to offer an opportunity for social inclusion and a sense of involvement.
The comparison group will receive the same educational and provider support materials as the Facebook group but will receive it via email. Both groups will have the opportunity for weekly education classes and typical peer interactions.
Upon cardiac rehabilitation completion or dropout, post-data will be collected. It is anticipated that this pilot will take up to one year and will be completed when 30 participants for each group have been obtained.
Data Analysis Statistical Methods. This is a feasibility study and the sample size obtained will determine if the study is appropriately powered to detect the desired effect size. Patient characteristics will be summarized group using frequencies and percentages for categorical factors, and means and standard deviations for continuous measures. In order to examine the primary outcome, differences in change in motivation between groups, overall motivation using the RAI from the BREQ-3 will be evaluated using analysis of covariance (ANCOVA) models. Mean differences with 95% confidence intervals for group differences will be presented. Multivariate analysis of variance models will be used to evaluate differences in the change across individual motivation subtypes (regulations), using the BREQ-3, between groups overall. If significant, separate ANCOVA models for each subtype will be fit. Similar models will be used to compare changes in needs satisfaction scores, overall and separately among the three subscales, between groups. Two-sample t-tests will be used to compare number of sessions completed. As a secondary analysis, the relationships between patient characteristics, "hits" and "likes", and the outcome variables RAI change, number of sessions, and needs satisfaction change will be examined using t-tests and Pearson correlations. The correlation between changes in RAI and needs satisfaction will also be evaluated. Analyses will be performed using SAS software (version 9.4; Cary, NC). An overall significance level of 0.05 will be assumed for all tests.
Sample Size. The investigators plan to enroll 30 patients in each group. In the first 9 months of 2016, cardiac rehabilitation at the main campus of this tertiary care center had approximately 170 patient intakes. It is assumed that there will be a similar number of patient intakes for a 9 month period in 2017. Based on Facebook participation rates for those over age 50 [21] and the high participation rates in previous research projects in this facility's cardiac rehabilitation, it is estimated that 40% may meet eligibility requirements and agree to participate. Allowing for use of the first 8 participants to establish the Facebook group, the estimated sample size would then be 60 total participants for randomization to study group who can then be included in analysis. With this sample size, there will be 86% power to detect large effect sizes (d=0.8) for our study outcomes [40]. The primary aim of this sample size determination is to evaluate whether the proposed intervention is feasible, and to estimate the differences that might exist so that a larger trial that would have adequate power to detect smaller differences could be designed based on what was learned in this pilot study. The sample size of 30 per group was chosen primarily to facilitate a large intervention group, since the value of the intervention is predicated upon interaction among the participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facebook group | Experimental | Behavioral: FacebookThe Facebook group will receive peer support, education and provider support via social media. |
| Comparison group | Active comparator | Behavioral: FacebookThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facebook1. 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. | Behavioural | Comparison group, Facebook group |
Primary outcome
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)
1 secondary outcome
Adherence
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 24875979Coyan GN, Reeder KM, Vacek JL, Coyan GN, Reeder KM, Vacek JL. Diet and exercise interventions following coronary artery bypass graft surgery: a review and call to action. Phys Sportsmed. 2014 May;42(2):119-29. doi: 10.3810/psm.2014.05.2064.
- Background: PubMed 3320334Deci EL, Ryan RM. The support of autonomy and the control of behavior. J Pers Soc Psychol. 1987 Dec;53(6):1024-37. doi: 10.1037//0022-3514.53.6.1024.
- Background: PubMed 10620381Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.
- Background: PubMed 11392867Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.
- Background: PubMed 27500157Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33.
- Background: PubMed 21946418Savage PD, Sanderson BK, Brown TM, Berra K, Ades PA. Clinical research in cardiac rehabilitation and secondary prevention: looking back and moving forward. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):333-41. doi: 10.1097/HCR.0b013e31822f0f79.
- Background: PubMed 27386722Servey JT, Stephens M. Cardiac Rehabilitation: Improving Function and Reducing Risk. Am Fam Physician. 2016 Jul 1;94(1):37-43.
- Background: PubMed 20808157Thomas 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.
- Background: PubMed 17070142Williams 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.
- BackgroundDeci EL, Ryan RM. Intrinsic Motivation and Self-determination in Human Behavior. New York, NY: Plenum Press. 1985. ISBN: 978-1-4899-2273-1.
- BackgrounddeCharms R. Personal Causation. New York, NY: Academic Press. 1968. ISBN 13: 9780122085505.
- Results publication: PubMed 26068087Balatsoukas 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.
- Pew ResearchLink provided by the sponsor.
- Exercise motivation measurementLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee A Siegmund, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook in people with Cardiovascular Diseases, run by The Cleveland Clinic 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 1 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: finished, as of the sponsor's last update on 27 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02971813, which also lists 40 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 27 Mar 2020.