Clinical trial NCT04426630: mHealth for Self-care of Heart Failure in Uganda
Official title: An Accessible, Scalable, Patient-facing mHealth Application for Self-care of Heart Failure in LMIC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Telemedicine
Uganda
mHealth
Implementation Science
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Makerere University
name: Uganda Heart Institute
name: University Health Network, Toronto
First posted: 2020-06-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participants will be asked to initiate self-care sessions using the Medly Uganda application. They will dial the sub-code and enter a unique PIN to access the system. They are asked to do this every Monday, Wednesday, and Friday morning for six months, as well as anytime that they experience concerning symptoms. If a participant has not initiated a session by 11:00am on the designated days, the application will generate an SMS reminder. Each interactive session will present a series of symptom-based questions to the participant. These questions will be followed by a tailored SMS message. While session content will not remain on the participant's phone, the SMS messages will. This allows participants to retain and review messages, thereby reinforcing educational content. There are four status categories: Stable, Fluid Overload, Urgent, and Critical. If Stable, participants will be sent one of six encouraging and educational messages. If Fluid Overload, Urgent or Critical, patient participants will be sent a message that identifies the symptom and recommends an action and the on-duty nurse will be sent an accompanying alert. Urgent and Critical alerts will also be sent to the on-duty doctor. The nurse is expected to call the patient for Urgent and Critical alerts within 60 and 15 minutes, respectively. Nurse phone call interactions will be guided by a standard operating manual. One nurse and one doctor will be designated rotating 'on-duty' responsibility to monitor clinician alerts and the dashboard seven days a week. The doctor will be available to provide clinical supervision to the nurse as needed and they will have a daily in-person or by-phone.

Eligibility criteria: Inclusion Criteria:

* UHI patient presenting for routine or urgent outpatient visit
* Currently living in Uganda and not planning to travel abroad for six months
* Age \>=18 years
* Symptomatic heart failure (New York Heart Association Class II or III and left ventricular ejection fraction of 45% or less)
* Access to a mobile phone
* Basic reading skills in English, Luganda, and/or Runyankole

Exclusion Criteria:

* Life expectancy \< six months
* Active medical condition requiring hospitalization, such as cardiac ischemia (acute electrocardiographic changes and/or positive biomarkers, if available), syncope, or significant fluid overload
* Pregnancy
* Inability to provide informed consent.

Primary outcomes:
measure: Self-Care for Heart Failure Index, Maintenance
timeFrame: Baseline and Six-month follow-up
measure: Self-Care for Heart Failure Index, Management
timeFrame: Baseline and Six-month follow-up
measure: Self-Care for Heart Failure Index, Confidence
timeFrame: Baseline and Six-month follow-up
Secondary outcomes:
measure: EQ-5D-5L, Mobility
timeFrame: Baseline and Six-month follow-up visit
measure: EQ-5D-5L, Self-Care
timeFrame: Baseline and Six-month follow-up visit
measure: EQ-5D-5L, Usual Activities
timeFrame: Baseline and Six-month follow-up visit
measure: EQ-5D-5L, Pain or Discomfort
timeFrame: Baseline and Six-month follow-up visit
measure: EQ-5D-5L, Anxiety or Depression
timeFrame: Baseline and Six-month follow-up visit
measure: EQ-5D-5L, VAS
timeFrame: Baseline and Six-month follow-up visit
measure: Six-Minute Walk Test, Total Distance
timeFrame: Baseline and Six-month follow-up visit
measure: Left Ventricular Ejection Fraction
timeFrame: Baseline and Six-month follow-up visit
measure: Frequency of Acute Care Visits
timeFrame: Baseline and Six-month follow-up visit
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Heart Institute
Study officials:
affiliation: Yale University
name: Jeremy Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Heart Institute
name: Isaac Ssinabulya, MMed
role: PRINCIPAL_INVESTIGATOR
References: