CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
mHealth for heart failure patients in Ugandaother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04426630
NCT04426630N/ACompleted

An Accessible, Scalable, Patient-facing mHealth Application for Self-care of Heart Failure in LMIC

Yale University·interventional·Posted Jun 11, 2020·Updated Dec 7, 2022

In Brief

A clinical study evaluating mHealth for heart failure patients in Uganda for Heart Failure. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Heart failure affects more than 38 million people globally. It is responsible for high rates of hospitalization and premature mortality, especially in sub-Saharan Africa. Heart failure causes multiple debilitating and distressing symptoms. These symptoms can often be managed by patients themselves but only when they are able to identify symptoms and select appropriate actions. Self-care, a World Health Organization-endorsed intervention for chronic conditions like heart failure, is greatly underutilized in lower and middle income countries, including Uganda. Self-care refers to the ability of patients, caregivers and communities to maintain health, prevent disease, and manage illness, with or without a healthcare provider. Mobile health (mHealth) offers a promising platform to address this need gap in lower and middle income countries. mHealth takes advantage of the widespread usage of mobile phones to offer patients individualized self-care tools such as education, healthy lifestyle prompts, and support with making decisions. Since 2016, this multidisciplinary, international research team has been designing Medly Uganda, an mHealth application to improve self-care among Ugandan patients with heart failure. This application began as a smartphone but was adapted for the low-cost feature phones used widely throughout the country. It was also integrated into an mHealth system endorsed by the Ugandan Ministry of Health. When patients log in they are prompted to report on specific heart failure symptoms. The application then generates self-care instructions based on those symptoms. If a patient reports serious symptoms the application triggers an alert to the research nurse, who then consults with the patient, caregiver, and if needed, cardiologist, to establish a plan of care. This study proposes that an mHealth intervention tailored specifically to the local context will improve healthcare quality of life for patients with heart failure. The research team hypothesizes that heart failure patients who use the program will report improved scores on the Self-Care in Heart Failure Index. These scores will be assessed at baseline, three-month, and six-month visits. The researchers will also measure changes in patients' clinical conditions, including the 6-minute walk test, left ventricular ejection fraction, and frequency of acute care visits. Finally, the researchers will conduct qualitative interviews with patients and providers to understand their experiences.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUganda

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartOct 19, 2020
Primary CompletionSep 6, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.1 years ago

Interventions

mHealth for heart failure patients in Ugandaother

Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.