CTRI/2021/01/030576 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On:
25/08/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive Process of Care Changes Behavioral
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
testing of a smartphone based remote monitoring application and behavioural interventions to improve selfcare in patients with chronic heart failure
Scientific Title of Study
A multicenter, randomized controlled trial evaluating a theory driven, behavior change intervention centered on mobile health and task sharing to improve self-care and outcomes in patients with chronic heart failure. PANACEA- HF trial (Part of the PANACEA -HF project)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Deepak Y Kamath
Designation
Assistant Professor
Affiliation
st. Johns Research Institute/ St. Johns National Academy of Health Sciences
Address
Dr Deepak Kamath
Department of Pharmacology St Johns Medical College Hospital
Division of Clinical Research and Training St Johns Research institute Koramangala Bangalore 34 Karnataka
Bangalore KARNATAKA 560034 India
Phone
9945519522
Fax
Email
kamath.deepak@sjri.res.in
Details of Contact Person Scientific Query
Name
Deepak Y Kamath
Designation
Assistant Professor
Affiliation
st. Johns Research Institute/ St. Johns National Academy of Health Sciences
Address
Dr Deepak Kamath,
Department of Pharmacology, St Johns Medical College Hospital,
Division of Clinical Research and Training,St Johns Research institute, Koramangala, Bangalore-34, Karnataka.
Bangalore KARNATAKA 560034 India
Phone
9945519522
Fax
Email
kamath.deepak@sjri.res.in
Details of Contact Person Public Query
Name
Immaculate Sheela Josephine
Designation
Study Coordinator
Affiliation
st Johns Research Institute St. Johns National Academy of Health Sciences
Address
Immacualte sheela Josephine J, Study Coordinator
Division of Clinical Research and Training St Johns Research institute Koramangala Bangalore 34 Karnataka
Bangalore KARNATAKA 560034 India
Phone
9148616862
Fax
Email
immaculate.sj@sjri.res.in
Source of Monetary or Material Support
India Alliance DBT Wellcome trust, 2nd Floor, Nishant House, 8-2-351/N/1, Rd Number 2, Venkateshwara Hills, Banjara Hills, Hyderabad, Telangana 500034
Primary Sponsor
Name
St Johns Research Institute
Address
opposite to koramangala BDA complex, Koramangala, Bangalore-34
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
India Alliance DBT Wellcome trust
Banjara hills, Secunderabad, Telangana state, India
Countries of Recruitment
India
Sites of Study
No of Sites = 3
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Rony Mathew
Lisie hospital
Cardiology Research,5th floor, St Anthonys block,Lisie Hospital Road, North Kaloor, Kaloor, Ernakulam, Kerala 682018 Kottayam KERALA
selfcare behavior change intervention involving task sharing, brief psychological intervention and remote monitoring of chronic heart failure patients
The intervention package will be delivered by a non-physician health worker supported by a physician, MBBS/MD Medicine/MD Community Medicine/ MD Pharmacology, A Remote monitoring Via Smartphone App Suhriday Patients or their caregivers who opt for the smartphone, use the Suhriday application to report symptom and sign worsening, self-measured blood pressure, heart rate and fluid intake, WhatsApp based Patients who do not opt for Suhriday, will be asked to note parameters in a paper diary, a photo taken and sent to the NPHW trained lay health worker, nurse or allied health science professional)daily via WhatsApp, The NPHW will also take calls from these patients if they want to report symptom or sign worsening or in an emergency situation. Structured telephone support Patients who do not opt for any smartphone intervention, will be offered structured telephone support, The NPHW makes active calls to these patients on a weekly basis in the first month after recruitment and monthly thereafter to provide structured telephone support. Patients based on their financial situation will be given a smartphone, validated electronic BP measuring device, a weighing scale and a measuring flask, for fluid measurement and a monthly payment of Rs.150/- for internet top-up, Patients who opt for structured telephone support will be paid Rs.50/- per month and a paper diary for documenting self-care, B Task-sharing Will involve two cadres of personnel, 1 A trained non-physician health worker at baseline will Document socio-economic status, establish rapport with patients and caregivers and evaluate for elements of an extant negative cycle using a questionnaire , Ascertain the patient’s explanatory model of disease and educate the patient in different aspects of self-care , Deliver a brief intervention to internalize the patient’s locus of control and counter passivity by involving the patient in formulating a self-care, plan and encouraging her/him to take responsibility for their own daily monitoring and maintenance Train patient on using the Omron device, weight and fluid measurement and the smartphone app (Suhriday). App-based monitoring , Triage reports from the patients and escalate to cardiology or medicine or to the pharmacologist, tele-consult with patient to gather information and pass along to the treating team, Arrange for a video-call consultation if needed, Collect revised prescriptions from the treating team, and send a photo to the patient through Suhriday, Physician supervisor MD medicine, Pharmacology, Community medicine , Oversight of NPHW function ; Monthly review of all patients medication lists to identify opportunities for medicines optimization and escalating the same to the cardiologist/internist, Review of patients’ self-care at 1, 3, 6 and 9 months respectively, patients displaying sub-optimal self-care will be contacted by phone to re-inforce advice and will be met by NPHW at the next routine clinic visit
Comparator Agent
Standard of care from cardiology and medicine
Present standards of care at most tertiary care hospitals anecdotal at discharge and out-patient follow ups, involves advice on lifestyle modification and medication adherence by the cardiologist or internist and reinforcement of this advice, along with dose optimizations at subsequent out patient follow-ups or discharge following rehospitalizations, For this trial, we will ensure that we select good tertiary care centers staffed by full time cardiologists and internists, The control arm patients will receive care in accordance with the center’s standard of care, At the end of the study, we will give all patients education content which was given to the intervention group, Hospital telephone numbers will be provided for emergency contact, Patients in the standard care group will be followed up at 1 month in person to measure self-care SCHFI will not be used as administering it may improve selfcare by itself instead we will use an as yet unvalidated 6 item questionnaire with dichotomous responses to assess self-care in control, quality of life EQ5D5L and KCCQ12, clinical outcomes and medication persistence ascertained, at 3 months by telephone clinical outcomes, medication persistence, at 6 and 12 months respectively for clinical outcomes, self-care and quality of life assessment general quality of life using EQ5D5L and heart failure specific QoL using the KCCQ12 and medication persistence.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
In-patients,1,Patients with a clinical diagnosis of heart failure on a high ceiling diuretic,2,In NYHA class I, II or III after stabilization and shifted to the general ward, commenced on a Renin Angiotensin Aldosterone (RAAS) blocker and or a beta blocker or vasodilator,3 If in NYHA IV, daily dose of Furosemide or high ceiling diuretic equivalent 100 mg day at discharge
Out-patients, 1, Patients with a prior clinical diagnosis of chronic heart failure, 2, In NYHA class I, II or III with a history of at least 1 re-hospitalization in the last 12 months, 3, Currently on a RAAS blocker and or beta blocker vasodilator, 4, Either a history of or currently on a high ceiling diuretic
ExclusionCriteria
Details
In-patients, 1, Patients in acute heart failure with a reversible cause for heart failure as judged by the treating cardiologist or internist, 2, Acute Kidney Injury due to heart failure which precludes the use of Renin,Angiotensin,Aldosterone blockers until discharge maybe considered for inclusion during OPD follow-up if RAAS blockers commenced, 3, Diagnosed with end stage renal disease or requiring renal replacement therapy, 4, Hemodynamic instability or shock requiring vasopressors in the current admission, 5, Patients with clinically diagnosed severe mental illness such as severe depression Or patients with moderate depression and no caregivers, 6, Patients having significant cognitive dysfunction during screening and have no caregiver, 7, Patients who in the opinion of the treating physician has a poor prognosis with foreseen survival less than 12 months
Out-patients, 1, Renal function status precludes the use of RAAS blockers, 2, End stage renal disease requiring any form of renal replacement therapy, 3, Patients having significant cognitive dysfunction during screening and have no caregiver, 4, Patients who in the opinion of the treating physician has a poor prognosis with foreseen survival less than 12 months.
Method of Generating Random Sequence
Adaptive randomization, such as minimization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
heart failure rehospitalization or all cause mortality
12 months
Secondary Outcome
Outcome
TimePoints
Secondary Outcome Measures, 1, average days in hospital per patient per month, 2,total heart failure rehospitalizations at 12 months, 3, death due to cardiovascular at 12 months, 4, quality of life scores using EQ5D5L and KCCQ12 at 1, 6 and 12 months, 5, persistence to RAAS blocker and beta-blockers at 1, 3, 6 and 12 months, change in selfcare score measured using Selfcare in heart failure index (SCHFI) from baseline to 1, 6 and 12 months in the intervention group
1 month, 3 months, 6 months and 12 months
Target Sample Size
Total Sample Size="300" Sample Size from India="300" Final Enrollment numbers achieved (Total)= "301" Final Enrollment numbers achieved (India)="301"
D.Y. Kamath, J. Abdullakutty, B.B. Granger, S. Kulkarni, K.B. Bhuvana, L.J. Salazar, S. Shifra, J. Idiculla, J. Narendra, K. Varghese, D. Xavier. A randomized controlled trial evaluating a theory driven, complex intervention centered on task sharing and mobile health to improve selfcare and outcomes in heart failure – The PANACEA-HF RCT: Design and rationale. American Heart Journal Plus: Cardiology Research and Practice. 2023. (Published Online: Article in Press).
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - All of the individual participant data collected during the trial, after de-identification.
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
Who will be able to view these files? Response - Researchers who provide a methodologically sound proposal.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response (Others) - Researchers will need to send their proposal with objectives, design, outcomes and analytical plan to Principal Investigator (kamath.deepak@sjri.res.in), copying the project sponsor (deansoffice.sjri.res.in). The sponsor and PI will review the proposal and revert with a response within 30 calendar days. If approved, the dataset that is de-identified by the Safe Harbour method will be made available to applicants.
For how long will this data be available start date provided 01-10-2022 and end date provided 30-09-2027? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - Nil
Brief Summary
The intervention aims to improve selfcare among patients with chronic heart failure with the objective of reducing heart failure related re-hospitalizations and mortality. The intervention comprises a trained health worker mediated, (i) systematic education (ii) simple evidence informed behaviour change techniques delivered by health workers, (iii) remote monitoring of symptoms and key patient parameters through telemedical modality respectively. The intervention will be on top of standard care and will be compared with the standard care only arm