Heart Failure Hospital Readmissions and Physical Therapy
NCT ID: NCT03517514
Last Updated: 2019-08-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
102 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-02-01
Study Completion Date
2019-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a dissertation study which is divided into three different studies in order to answer the main research question (Study 3). The primary aim of this research (dissertation) is to investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers of patients with Acute Decompensated Heart Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital.
Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?
Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
12-Week-Combined Physical Training In Heart Failure Patients
NCT02571270
Heart Failure Patients
COMPLETED
NA
High Intensity Interval Training in Heart Failure
NCT03032081
Heart Failure
Physical Activity
WITHDRAWN
NA
Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life
NCT02179242
Heart Failure
TERMINATED
NA
Rehabilitation and Exercise Training After Hospitalization
NCT01508650
Heart Failure
COMPLETED
NA
Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
NCT04688827
Heart Failure
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The research plan is to investigate how acute physical therapy can play a big role in lowering 30-day hospital readmission in patients discharged with acute decompensated heart failure (ADHF). Several factors will be used to investigate and predict 30-day hospital readmission. Such factors are (1) functional mobility; 2) psychosocial attributes; (3) number of follow ups with providers; (4) adherence to home exercise program; (5) and participation in a supervised exercise program. Functional mobility will be measured by four different functional outcome measurements such as 5 meter walk test (5mWT), 30 seconds sit to stand test (30STS), six minute walk test (6MWT), and time up and go test (TUG). The psychosocial attributes will be measured by three different, pen and paper, self-survey questionnaires namely Kansas City Cardiomyopathy Questionnaire-12 (KCCQ12), Hospital Anxiety and Depression Scale (HADS), ENRICHD Social Support Instrument (ESSI). Moreover, once the patient returns home, two phone surveys will be conducted (every two weeks) for a period of 30 days of hospital discharge as a follow up.
For the outcome measurements, the 5mWT is a simple test to measure individual's gait (walking) speed. The 30STS is a simple and easy test to complete in assessing functional lower extremity strength. The 30STS asks individual to stand up (assuming erect posture as much as possible with or without hands support) as many as possible from a regular chair with arm rest within 30 seconds timeframe. The 6MWT is simple and practical test is to measure aerobic capacity by measuring distance of an individual's ability to walk for 6 minutes. The TUG is to measure the time in seconds for a person to rise from sitting from a standard arm chair, rise, walk 10 feet, walk back to the previous arm chair, and sit down. The objective of the TUG test is to classify patient's fall risk. In addition, the functional mobility, basing on the functional outcome measures conducted, will be further assessed at the end of physical therapy service at the hospital by using Global Rating of Scale (GROC). The GROC is a self-survey using 5 point Likert scale, measuring how patient perceives the overall degree of change of improvement or perhaps a lack of improvement.
For the Psychosocial Measures, the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 is a shorter version of the original KCCQ tool. The objective of this test is to quantify self-measurement of physical function, symptoms, social function, self-efficacy and knowledge, and quality of life as it relates to their own heart failure diagnosis. The Hospital Anxiety and Depression Scale (HADS) is a self-reported questionnaire designed to measure the levels of anxiety and depression that an individual is experiencing. The objective of this tool is to serve as a screening tool to identify individuals who may suffer from anxiety and depression. The ENRICHD Social Support Instrument (ESSI) is a seven-item self-report survey that assesses patient's belief of their social support attributes (emotional, instrumental, informational, and appraisal).
For the outcome measurements, the 5mWT is a simple test to measure individual's gait (walking) speed. The 30STS is a simple and easy test to complete in assessing functional lower extremity strength. The 30STS asks individual to stand up (assuming erect posture as much as possible with or without hands support) as many as possible from a regular chair with arm rest within 30 seconds timeframe. The 6MWT is simple and practical test is to measure aerobic capacity by measuring distance of an individual's ability to walk for 6 minutes. The TUG is to measure the time in seconds for a person to rise from sitting from a standard arm chair, rise, walk 10 feet, walk back to the previous arm chair, and sit down. The objective of the TUG test is to classify patient's fall risk. In addition, the functional mobility, basing on the functional outcome measures conducted, will be further assessed at the end of physical therapy service at the hospital by using Global Rating of Scale (GROC). The GROC is a self-survey using 5 point Likert scale, measuring how patient perceives the overall degree of change of improvement or perhaps a lack of improvement.
For the Psychosocial Measures, the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 is a shorter version of the original KCCQ tool. The objective of this test is to quantify self-measurement of physical function, symptoms, social function, self-efficacy and knowledge, and quality of life as it relates to their own heart failure diagnosis. The Hospital Anxiety and Depression Scale (HADS) is a self-reported questionnaire designed to measure the levels of anxiety and depression that an individual is experiencing. The objective of this tool is to serve as a screening tool to identify individuals who may suffer from anxiety and depression. The ENRICHD Social Support Instrument (ESSI) is a seven-item self-report survey that assesses patient's belief of their social support attributes (emotional, instrumental, informational, and appraisal).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Acute Heart Failure
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physical Therapy service
routine physical therapy care
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* all admitted at Houston Methodist Hospital with a primary diagnosis of acute heart failure or similar type of medical diagnosis
* stable medical state (HR equal or greater than 50 bpm, mean BP of 60 mmHg or better, Oxygen saturation (with or without oxygen supplement) of 90% or better; RR of 15 or better
* 50 years old and over and able to follow 2 simple commands
* establish discharge recommendation to home settings
* ambulatory with or without assitive device(s)
* stable medical state (HR equal or greater than 50 bpm, mean BP of 60 mmHg or better, Oxygen saturation (with or without oxygen supplement) of 90% or better; RR of 15 or better
* 50 years old and over and able to follow 2 simple commands
* establish discharge recommendation to home settings
* ambulatory with or without assitive device(s)
Exclusion Criteria
* history of psychiatric disorder
* diagnosis of acute kidney injury requiring continuous renal replacement therapy
* diagnosis of major cognitive impairment (dementia, Alzheimer's dse, etc)
* inability to read and understand basic english language
* establish discharge recommendation to post-acute care settings (e.g. SNF, inpatient rehab, LTACH)
* inability to complete any functional mobility test due to musculoskeletal or other disorders
* diagnosis of acute kidney injury requiring continuous renal replacement therapy
* diagnosis of major cognitive impairment (dementia, Alzheimer's dse, etc)
* inability to read and understand basic english language
* establish discharge recommendation to post-acute care settings (e.g. SNF, inpatient rehab, LTACH)
* inability to complete any functional mobility test due to musculoskeletal or other disorders
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Texas Woman's University
OTHER
Sponsor Role
collaborator
The Methodist Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bobby Belarmino PT,DPT,MA
Senior Physical Therapist (Level IV)
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bobby C Belarmino, PT,DPT,MA
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Houston Methodist Hospital
Houston, Texas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Ross JS, Chen J, Lin Z, Bueno H, Curtis JP, Keenan PS, Normand SL, Schreiner G, Spertus JA, Vidan MT, Wang Y, Wang Y, Krumholz HM. Recent national trends in readmission rates after heart failure hospitalization. Circ Heart Fail. 2010 Jan;3(1):97-103. doi: 10.1161/CIRCHEARTFAILURE.109.885210. Epub 2009 Nov 10.
Reference Type
BACKGROUND
Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, Heidenreich PA, Yancy CW, Peterson ED, Curtis LH. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA. 2010 May 5;303(17):1716-22. doi: 10.1001/jama.2010.533.
Reference Type
BACKGROUND
Hines AL, Barrett ML, Jiang HJ, Steiner CA. Conditions With the Largest Number of Adult Hospital Readmissions by Payer, 2011. 2014 Apr. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #172. Available from http://www.ncbi.nlm.nih.gov/books/NBK206781/
Reference Type
BACKGROUND
McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation. 2015 May 19;131(20):1796-803. doi: 10.1161/CIRCULATIONAHA.114.010270. No abstract available.
Reference Type
BACKGROUND
Yamada S, Shimizu Y, Suzuki M, Izumi T; PTMaTCH collaborators. Functional limitations predict the risk of rehospitalization among patients with chronic heart failure. Circ J. 2012;76(7):1654-61. doi: 10.1253/circj.cj-11-1178. Epub 2012 Apr 7.
Reference Type
BACKGROUND
Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.
Reference Type
BACKGROUND
McCabe N, Butler J, Dunbar SB, Higgins M, Reilly C. Six-minute walk distance predicts 30-day readmission after acute heart failure hospitalization. Heart Lung. 2017 Jul-Aug;46(4):287-292. doi: 10.1016/j.hrtlng.2017.04.001. Epub 2017 May 24.
Reference Type
BACKGROUND
DiDomenico RJ, Park HY, Southworth MR, Eyrich HM, Lewis RK, Finley JM, Schumock GT. Guidelines for acute decompensated heart failure treatment. Ann Pharmacother. 2004 Apr;38(4):649-60. doi: 10.1345/aph.1D481. Epub 2004 Feb 24.
Reference Type
BACKGROUND
Alhurani AS, Dekker RL, Abed MA, Khalil A, Al Zaghal MH, Lee KS, Mudd-Martin G, Biddle MJ, Lennie TA, Moser DK. The association of co-morbid symptoms of depression and anxiety with all-cause mortality and cardiac rehospitalization in patients with heart failure. Psychosomatics. 2015 Jul-Aug;56(4):371-80. doi: 10.1016/j.psym.2014.05.022. Epub 2014 Jun 2.
Reference Type
BACKGROUND
Fisher SR, Kuo YF, Sharma G, Raji MA, Kumar A, Goodwin JS, Ostir GV, Ottenbacher KJ. Mobility after hospital discharge as a marker for 30-day readmission. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):805-10. doi: 10.1093/gerona/gls252. Epub 2012 Dec 19.
Reference Type
BACKGROUND
Fisher SR, Graham JE, Ottenbacher KJ, Deer R, Ostir GV. Inpatient Walking Activity to Predict Readmission in Older Adults. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S226-31. doi: 10.1016/j.apmr.2015.09.029. Epub 2016 Jun 2.
Reference Type
BACKGROUND
Reeves GR, Whellan DJ, Duncan P, O'Connor CM, Pastva AM, Eggebeen JD, Hewston LA, Morgan TM, Reed SD, Rejeski WJ, Mentz RJ, Rosenberg PB, Kitzman DW; REHAB-HF Trial Investigators. Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale. Am Heart J. 2017 Mar;185:130-139. doi: 10.1016/j.ahj.2016.12.012. Epub 2016 Dec 28.
Reference Type
BACKGROUND
Wilson CM, Kostsuca SR, Boura JA. Utilization of a 5-Meter Walk Test in Evaluating Self-selected Gait Speed during Preoperative Screening of Patients Scheduled for Cardiac Surgery. Cardiopulm Phys Ther J. 2013 Sep;24(3):36-43.
Reference Type
BACKGROUND
Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.
Reference Type
BACKGROUND
Tabata M, Shimizu R, Kamekawa D, Kato M, Kamiya K, Akiyama A, Kamada Y, Tanaka S, Noda C, Masuda T. Six-minute walk distance is an independent predictor of hospital readmission in patients with chronic heart failure. Int Heart J. 2014;55(4):331-6. doi: 10.1536/ihj.13-224. Epub 2014 Jun 5.
Reference Type
BACKGROUND
Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
Reference Type
BACKGROUND
Herman T, Giladi N, Hausdorff JM. Properties of the 'timed up and go' test: more than meets the eye. Gerontology. 2011;57(3):203-10. doi: 10.1159/000314963. Epub 2010 May 20.
Reference Type
BACKGROUND
Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. doi: 10.1161/CIRCOUTCOMES.115.001958.
Reference Type
BACKGROUND
Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
Reference Type
BACKGROUND
Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. No abstract available.
Reference Type
BACKGROUND
Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
Reference Type
BACKGROUND
Vaglio J Jr, Conard M, Poston WS, O'Keefe J, Haddock CK, House J, Spertus JA. Testing the performance of the ENRICHD Social Support Instrument in cardiac patients. Health Qual Life Outcomes. 2004 May 13;2:24. doi: 10.1186/1477-7525-2-24.
Reference Type
BACKGROUND
Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. doi: 10.1097/00008483-200311000-00001. No abstract available.
Reference Type
BACKGROUND
Garrison C, Cook C. Clinimetrics corner: the Global Rating of Change Score (GRoC) poorly correlates with functional measures and is not temporally stable. J Man Manip Ther. 2012 Nov;20(4):178-81. doi: 10.1179/1066981712Z.00000000022.
Reference Type
BACKGROUND
Schmitt J, Abbott JH. Global ratings of change do not accurately reflect functional change over time in clinical practice. J Orthop Sports Phys Ther. 2015 Feb;45(2):106-11, D1-3. doi: 10.2519/jospt.2015.5247. Epub 2015 Jan 8.
Reference Type
BACKGROUND
Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
Reference Type
BACKGROUND
Walenkamp MM, de Muinck Keizer RJ, Goslings JC, Vos LM, Rosenwasser MP, Schep NW. The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures. Clin Orthop Relat Res. 2015 Oct;473(10):3235-41. doi: 10.1007/s11999-015-4376-9. Epub 2015 Jun 4.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.heartfailurematters.org/en_GB
Heart Failure matters
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00018201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
NCT05002075
COMPLETED
NA
Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
NCT03615157
UNKNOWN
NA
Effects of Early Cardiopulmonary Rehabilitation in Patients With Acute Decompensated Heart Failure
NCT07155421
RECRUITING
NA
Efficacy of Physical Exercise in Cardiac Rehabilitation
NCT01617850
COMPLETED
NA
High-intensity Interval Versus Combined Exercise Training in CHF
NCT02387411
UNKNOWN
NA
Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
NCT01914315
UNKNOWN
NA
Rehabilitation for Older Adults From Acute Medical Conditions
NCT00038155
COMPLETED
PHASE2
Efficacy of a Home-Based Exercise Program for Heart Failure
NCT01407185
TERMINATED
NA
Cardiovascular Effects of Acute Exercise Post-Stroke
NCT03570216
COMPLETED
NA
Effects of In-Hospital Cardiac Rehabilitation and Manual Lymphatic Drainage in Acute Decompensated Heart Failure
NCT07095764
COMPLETED
NA
Frailty in Individuals With Advanced Heart Failure Part 2
NCT05127785
WITHDRAWN
Cardiac Rehab Post-atrial Fib Ablation
NCT05450731
COMPLETED
NA
Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
NCT00937443
COMPLETED
Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure.
NCT06222762
RECRUITING
NA
High Intensity Interval Training in Chronic Heart Failure
NCT05659420
RECRUITING
NA
The Impact of Cardiac Rehabilitation Exercise Therapy on the Quality of Life of Patients With Chronic Heart Failure
NCT06633107
NOT_YET_RECRUITING
NA
High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction
NCT02916225
COMPLETED
NA
Enhancement of Physical Activity in Elderly Patients With Diastolic Heart Failure by a Motivational Intervention
NCT03402490
COMPLETED
NA
Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
NCT05255172
ENROLLING_BY_INVITATION
NA
Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation
NCT03506737
UNKNOWN
NA
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
NCT07118410
NOT_YET_RECRUITING
NA
Effects of Exercise Training on Fluid Instability in Heart Failure Patients
NCT01375673
COMPLETED
NA
Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
NCT03385837
COMPLETED