mHealth for Self-care of Heart Failure in Uganda

NCT04426630 | Completed Results

• 2 other identifiers: 20000253381R21TW010998-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Telemedicine; Uganda; mHealth; Implementation Science

Outcome Measures

Primary Outcomes (3)

• Self-Care for Heart Failure Index, Maintenance

  The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.

  Baseline and Six-month follow-up

• Self-Care for Heart Failure Index, Management

  The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.

  Baseline and Six-month follow-up

• Self-Care for Heart Failure Index, Confidence

  The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence

  Baseline and Six-month follow-up

Secondary Outcomes (9)

• EQ-5D-5L, Mobility

  Baseline and Six-month follow-up visit

• EQ-5D-5L, Self-Care

  Baseline and Six-month follow-up visit

• EQ-5D-5L, Usual Activities

  Baseline and Six-month follow-up visit

• EQ-5D-5L, Pain or Discomfort

  Baseline and Six-month follow-up visit

• EQ-5D-5L, Anxiety or Depression

  Baseline and Six-month follow-up visit

Study Arms (1)

mHealth

OTHER

Heart failure patients enrolled in the mHealth program

Other: mHealth for heart failure patients in Uganda

Interventions

mHealth for heart failure patients in Uganda OTHER

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.

mHealth

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Makerere University: collaborator
• Uganda Heart Institute: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Jeremy Schwartz
• Organization: Yale University School of Medicine

jeremy.schwartz@yale.edu

2036801598

Study Officials

• Jeremy Schwartz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Isaac Ssinabulya, MMed

  Uganda Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: October 19, 2020
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: December 7, 2022
• Results First Posted: August 10, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)