Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Proof-of-Concept Study of a Smartphone Application Created to Improve Management of Ambulatory Patients With Heart Failure: the Heart Failure Heart Habits Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238729
• Other study ID #: CHF-MGH-001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: March 5, 2018

Study information

• Verified date: May 2018
• Source: Jana Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses the ability of ambulatory patients with heart failure (HF) to use a smartphone application created for the management of patients with chronic HF. This study will aim:

• To understand the frequency with which ambulatory HF patients engage with this smartphone application.

• To determine whether patient's knowledge of HF and its management has improved with the use of this smartphone application.

• To assess improvement in quality of life measures related to the use of this smartphone application.

• To assess improvement in lifestyle measures related to the use of this smartphone application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of HFrEF or HFpEF. HFrEF defined as clinical signs and symptoms of HF with a left ventricular (LV) EF = 40% by any imaging modality AND at least 1 hospitalization or emergency department (ED) visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. HFpEF defined as clinical signs and symptoms of HF with an LVEF = 50% by any imaging modality and at least 1 hospitalization or ED visit for HF or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment.

• Adult patients, men and women, > 18 years old.

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Heart Failure Education and Management App
Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.
• Heart Failure Literature
Patients will be provided standard literature about heart failure and the management of heart failure.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Jana Care	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bonin CD, Santos RZ, Ghisi GL, Vieira AM, Amboni R, Benetti M. Construction and validation of a questionnaire about heart failure patients' knowledge of their disease. Arq Bras Cardiol. 2014 Apr;102(4):364-73. doi: 10.5935/abc.20140032. Epub 2014 Feb 17. English, Portuguese. — View Citation

Gardetto NJ. Self-management in heart failure: where have we been and where should we go? J Multidiscip Healthc. 2011 Mar 31;4:39-51. doi: 10.2147/JMDH.S8174. — View Citation

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. — View Citation

Konstam MA. Home monitoring should be the central element in an effective program of heart failure disease management. Circulation. 2012 Feb 14;125(6):820-7. doi: 10.1161/CIRCULATIONAHA.111.031161. — View Citation

Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882. — View Citation

Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362. — View Citation

Reilly CM, Higgins M, Smith A, Gary RA, Robinson J, Clark PC, McCarty F, Dunbar SB. Development, psychometric testing, and revision of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):500-9. doi: 10.1097/JCN.0b013e3181aff0b0. — View Citation

Shaw JD, O'Neal DJ 3rd, Siddharthan K, Neugaard BI. Pilot program to improve self-management of patients with heart failure by redesigning care coordination. Nurs Res Pract. 2014;2014:836921. doi: 10.1155/2014/836921. Epub 2014 Apr 23. — View Citation

Sochalski J, Jaarsma T, Krumholz HM, Laramee A, McMurray JJ, Naylor MD, Rich MW, Riegel B, Stewart S. What works in chronic care management: the case of heart failure. Health Aff (Millwood). 2009 Jan-Feb;28(1):179-89. doi: 10.1377/hlthaff.28.1.179. — View Citation

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. — View Citation

Vieira AM, Costa IZ, Oh P, Lima de Melo Ghisi G. Questionnaires Designed to Assess Knowledge of Heart Failure Patients: A Systematic Review. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):469-78. doi: 10.1097/JCN.0000000000000281. Review. — View Citation

White MF, Kirschner J, Hamilton MA. Self-care guide for the heart failure patient. Circulation. 2014 Jan 21;129(3):e293-4. doi: 10.1161/CIRCULATIONAHA.113.003991. — View Citation

WRITING COMMITTEE MEMBERS; ACC/AHA TASK FORCE MEMBERS. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2016 Sep;22(9):659-69. doi: 10.1016/j.cardfail.2016.07.001. Epub 2016 Jul 6. — View Citation

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients that complete the curriculum	Total number of patients who complete the lessons on the app	6 weeks
Primary	Frequency of app use	Measuring how often and how long patients engaged with the app	6 weeks
Secondary	Score on Atlanta HF Knowledge Test	Assess patients knowledge of heart failure before and after study	6 weeks
Secondary	Score on Kansas City Cardiomyopathy Questionnaire-12	Assess changes in patients self-reported quality of life	6 weeks
Secondary	%change in weekly activity as measured by steps	Assess changes in lifestyle measures (diet, activity, etc.)	6 weeks
Secondary	Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking	Compare baseline to end of study on a questionnaire	6 weeks