N/A
N=72
mHealth for Self-care of Heart Failure in Uganda
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04426630 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Self-Care for Heart Failure Index, Maintenance — 35; 85 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mHealth for heart failure patients in Uganda (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Care for Heart Failure Index, Maintenance |
35; 85 | <0.001 sig |
| PRIMARY Self-Care for Heart Failure Index, Management |
20; 85 | <0.001 sig |
| PRIMARY Self-Care for Heart Failure Index, Confidence |
41.2; 97.1 | <0.001 sig |
| SECONDARY EQ-5D-5L, Mobility |
47; 25; 54; 12 | 0.028 sig |
| SECONDARY EQ-5D-5L, Self-Care |
42; 30; 58; 8 | <0.001 sig |
| SECONDARY EQ-5D-5L, Usual Activities |
33; 39; 54; 12 | <0.001 sig |
| SECONDARY EQ-5D-5L, Pain or Discomfort |
42; 30; 45; 21 | 0.23 |
| SECONDARY EQ-5D-5L, Anxiety or Depression |
44; 28; 57; 9 | <0.001 sig |
| SECONDARY EQ-5D-5L, VAS |
70; 80 | <0.001 sig |
| SECONDARY Six-Minute Walk Test, Total Distance |
320.3; 340.0 | <0.001 sig |
| SECONDARY Left Ventricular Ejection Fraction |
30; 33.0 | 0.07 |
| SECONDARY Frequency of Acute Care Visits |
56; 12; 4; 60; 6; 0 | <0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04426630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.