NCT03517514

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

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

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

April 6, 2018

Last Update Submit

August 28, 2019

Conditions

Keywords

Heart FailurePhysical TherapyHospital Readmission

Outcome Measures

Primary Outcomes (1)

  • hospital readmission within 30 days

    Identification of patient hospital readmission within 30 days of discharge (day 0).

    less than or equal to 30 days

Secondary Outcomes (5)

  • Six Minute Walk Test (6MWT)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • 30 seconds Sit to Stand Test (30STS)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • Five Meter Walk Test (5mWT)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • Time Up and Go Test of Fall Risk (TUG)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • Global Rating of Change Scale (GROC)

    End of study (post-physical therapy; defined as time frame: Day 2 to 8 weeks)

Other Outcomes (3)

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • Hospital Anxiety and Depresssion Scale (HADS)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

  • Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI)

    Comparing any change between pre-physical therapy treatment (Day 1) to post-physical therapy treatment (defined as time frame: Day 2 to 8 weeks)

Interventions

routine physical therapy care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All medically stable, admitted patients at the hospital that have an admitting diagnosis of acute heart failure (or similar diagnosis) will be screened as potential study participants.

You may qualify if:

  • 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
  • years old and over and able to follow 2 simple commands
  • establish discharge recommendation to home settings
  • ambulatory with or without assitive device(s)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (27)

  • 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.

    PMID: 19903931BACKGROUND
  • 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.

    PMID: 20442387BACKGROUND
  • 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/

    PMID: 24901179BACKGROUND
  • 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.

    PMID: 25986448BACKGROUND
  • 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.

    PMID: 22484978BACKGROUND
  • 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.

    PMID: 22825412BACKGROUND
  • 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.

    PMID: 28551310BACKGROUND
  • 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.

    PMID: 14982975BACKGROUND
  • 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.

    PMID: 25556571BACKGROUND
  • 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.

    PMID: 23254776BACKGROUND
  • 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.

    PMID: 27264549BACKGROUND
  • 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.

    PMID: 28267466BACKGROUND
  • 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.

    PMID: 23997690BACKGROUND
  • 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.

    PMID: 21050978BACKGROUND
  • 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.

    PMID: 24898596BACKGROUND
  • 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.

    PMID: 10380242BACKGROUND
  • 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.

    PMID: 20484884BACKGROUND
  • 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.

    PMID: 26307129BACKGROUND
  • 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.

    PMID: 10758967BACKGROUND
  • 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.

    PMID: 25005549BACKGROUND
  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PMID: 12914662BACKGROUND
  • 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.

    PMID: 15142277BACKGROUND
  • 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.

    PMID: 14646785BACKGROUND
  • 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.

    PMID: 24179325BACKGROUND
  • 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.

    PMID: 25573006BACKGROUND
  • 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.

    PMID: 20046623BACKGROUND
  • 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.

    PMID: 26040969BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Bobby C Belarmino, PT,DPT,MA

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physical Therapist (Level IV)

Study Record Dates

First Submitted

April 6, 2018

First Posted

May 7, 2018

Study Start

February 1, 2018

Primary Completion

January 31, 2019

Study Completion

August 28, 2019

Last Updated

August 29, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations