Heart FailureNCT03238729

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

A study testing Heart Failure Education and Management App and Heart Failure Literature in people with Heart Failure, run by Jana Care at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Heart Failure Education and Management App and Heart Failure Literature
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2017to 5 Mar 2018
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

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.

Who cannot join

Pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Conditions: Heart Failure
Being tested: Heart Failure Education and Management App, Heart Failure Literature
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heart Failure Education and Management AppBehavioural
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 LiteratureBehavioural
Patients will be provided standard literature about heart failure and the management of heart failure.

Study groups in NCT03238729
Study group	Role	What they receive
CHF App	Experimental	Patients will be provided with a mobile app on a smartphone for education and management of heart failure. Receives: Behavioral: Heart Failure Education and Management App
Standard of Care	Active comparator	Patients will be provided standard literature on heart failure management. Receives: Behavioral: Heart Failure Literature

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients that complete the curriculum
Total number of patients who complete the lessons on the app
Measured: 6 weeks
Frequency of app use
Measuring how often and how long patients engaged with the app
Measured: 6 weeks

Secondary outcomes (4)

Score on Atlanta HF Knowledge Test
Assess patients knowledge of heart failure before and after study
Measured: 6 weeks
Score on Kansas City Cardiomyopathy Questionnaire-12
Assess changes in patients self-reported quality of life
Measured: 6 weeks
%change in weekly activity as measured by steps
Assess changes in lifestyle measures (diet, activity, etc.)
Measured: 6 weeks
Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking
Compare baseline to end of study on a questionnaire
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 20175 Mar 2018

First posted3 Aug 2017
Study start21 Sep 2017
Primary completion5 Mar 2018
Study completion5 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03238729
Sponsor's protocol ID: CHF-MGH-001
Status last verified: May 2018
First submitted: 28 Jul 2017
Last updated: 9 May 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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. No abstract available.
PubMed 24352519
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. No abstract available.
PubMed 22331919
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.
PubMed 21544247
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.
PubMed 20858878
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.
PubMed 24864206
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. No abstract available.
PubMed 24446413
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.
PubMed 19124869
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.
PubMed 24652054
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.
PubMed 27302310
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. No abstract available.
PubMed 23741057
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. No abstract available.
PubMed 27394189
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.
PubMed 26307129
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.
PubMed 26208265
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.
PubMed 19858959
Wei KS, Ibrahim NE, Kumar AA, Jena S, Chew V, Depa M, Mayanil N, Kvedar JC, Gaggin HK. Habits Heart App for Patient Engagement in Heart Failure Management: Pilot Feasibility Randomized Trial. JMIR Mhealth Uhealth. 2021 Jan 20;9(1):e19465. doi: 10.2196/19465.
PubMed 33470941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03238729
Acronym / sponsor ID: CHF-MGH-001
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Jana CareIndustry (pharma, biotech, devices)
Collaborators: Massachusetts General Hospital
Study start: 21 Sep 2017 (actual)
Primary completion: 5 Mar 2018 (actual)
Study completion: 5 Mar 2018 (actual)
First posted: 3 Aug 2017 (actual)
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.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CHF App	Experimental	Behavioral: Heart Failure Education and Management AppPatients will be provided with a mobile app on a smartphone for education and management of heart failure.
Standard of Care	Active comparator	Behavioral: Heart Failure LiteraturePatients will be provided standard literature on heart failure management.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

Pregnant

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
Heart Failure Education and Management AppPatients 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.	Behavioural	CHF App
Heart Failure LiteraturePatients will be provided standard literature about heart failure and the management of heart failure.	Behavioural	Standard of Care

Primary outcome

Number of patients that complete the curriculum
Time frame: 6 weeks
Total number of patients who complete the lessons on the app
Frequency of app use
Time frame: 6 weeks
Measuring how often and how long patients engaged with the app

4 secondary outcomes

Score on Atlanta HF Knowledge Test
Time frame: 6 weeks
Score on Kansas City Cardiomyopathy Questionnaire-12
Time frame: 6 weeks
%change in weekly activity as measured by steps
Time frame: 6 weeks
Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking
Time frame: 6 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 9 May 2018.
Background: PubMed 24352519Go 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. No abstract available.
Background: PubMed 22331919Konstam 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. No abstract available.
Background: PubMed 21544247Gardetto 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.
Background: PubMed 20858878Powell 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.
Background: PubMed 24864206Shaw 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.
Background: PubMed 24446413White 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. No abstract available.
Background: PubMed 19124869Sochalski 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.
Background: PubMed 24652054Bonin 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.
Background: PubMed 27302310Masterson 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.
Background: PubMed 23741057Yancy 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. No abstract available.
Background: PubMed 27394189WRITING 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. No abstract available.
Background: PubMed 26307129Spertus 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.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Hanna K Gaggin, MD, MPH principal investigator

Massachusetts General Hospital

Nasrien E Ibrahim, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Heart Failure Education and Management App and Heart Failure Literature in people with Heart Failure, run by Jana Care 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 2 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 9 May 2018. 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?

Number of patients that complete the curriculum (time frame: 6 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 NCT03238729, which also lists 15 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 9 May 2018.