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Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital (FCR-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795936
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Moi Teaching and Referral Hospital
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 31, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date July 19, 2018
Study Start Date  ICMJE July 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Protocol adherence [ Time Frame: 12 weeks ]
Mean adherence of at least 25% to the exercise prescriptions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Change in 6 minute walk time distance (in meters) [ Time Frame: baseline, 12 weeks ]
    Measure of functional capacity
  • Change in Depression screen score using patient health questionnaire 9 (PHQ9) [ Time Frame: baseline, 12 weeks ]
    Screen score based on patient health questionnaire 9 (PHQ9)
  • Change in Quality of life using short form health survey (SF 36) score [ Time Frame: baseline, 12 weeks ]
    Quality of life based on short form health survey (SF 36) score
  • Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions [ Time Frame: 12 weeks ]
    Thematic analysis of barriers and incentives towards cardiac rehabilitation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital
Official Title  ICMJE Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital
Brief Summary

This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya.

This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.

Detailed Description

Cardiovascular diseases are major drivers of global disease burden. Heart failure, has a 50% mortality at 5 years and is thought to be higher in resource limited settings. Cardiac rehabilitation (CR) is a multi-disciplinary intervention which has been demonstrated to improve functional status, quality of life, and reduce morbidity and mortality in patients with heart failure. In sub-Saharan Africa, despite a significant heart failure disease burden, CR is largely non-existent. There is a compelling need for urgent development of access to CR in the region. However, feasibility and potential utilization of CR is unknown. The investigators aim to conduct a mixed methods study to evaluate feasibility of home based and institution based CR.

Participants will be voluntarily recruited from a convenience sample at the Moi Teaching and Referral Hospital (MTRH) outpatient cardiology clinic. Based on a reasonable estimate of expected subject recruitment over the time frame of study, 25 patients will be recruited into the institution based cardiac rehabilitation (IBCR) arm. In consideration of the potentially larger population and a wider geographical spread of home based cardiac rehabilitation (HBCR), 36 patients will be recruited to the HBCR arm and 40 patients will be recruited into an observational arm. While the study is not designed to make comparative outcome inferences between the HBCR and the IBCR groups, the sample size will be large enough to detect a clinically significant mean post intervention increase in 6 minute walk time distance in the HBCR arm of 50m.

The participants will be involved in physical exercises, nutritional counseling and educational sessions. Upon completion of the rehabilitation protocols, patients from both study arms will also be invited to participate in focus group discussions. Data will be analyzed and numeric data will be expressed as number (percent), means (standard deviation) or median (interquartile range). Wilcoxon rank-sum and Fisher's exact tests for pre - post intervention comparisons of continuous and binary variables, respectively. Focus group discussions will be transcribed and analyzed to identify discussion themes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE Procedure: Cardiac rehabilitation
Perform exercise prescription for 12 weeks
Other Name: exercise
Study Arms  ICMJE
  • Active Comparator: Institutional based rehabilitation
    Conduct cardiac rehabilitation exercise protocol within the hospital
    Intervention: Procedure: Cardiac rehabilitation
  • Active Comparator: Home based rehabilitation
    Conduct cardiac rehabilitation exercise protocol at home
    Intervention: Procedure: Cardiac rehabilitation
  • Placebo Comparator: Observational arm
    No prescribed exercises, followed up monthly
    Intervention: Procedure: Cardiac rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. New York Heart Association (NYHA) Class II and III heart failure
  2. Have had an echocardiographic study in the past 5 years
  3. Owns a mobile telephone
  4. Can participate in exercise
  5. Can read/ primary care giver can read in English or Kiswahili
  6. Can travel to hospital three times a week

Exclusion Criteria:

  1. Recent acute illness requiring hospitalization or initiation of new medication in the preceding 4 weeks
  2. Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced comorbidities
  3. Known arrhythmia
  4. Heart failure due to congenital heart disease
  5. Pregnant patients as may be confirmed by patient report or urine pregnancy tests
  6. Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis
  7. Presence of implanted pacemaker
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795936
Other Study ID Numbers  ICMJE Pro00071928
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Moi Teaching and Referral Hospital
Investigators  ICMJE
Principal Investigator: Gerald S Bloomfield, MD Duke Universisty
PRS Account Duke University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP