mHealth for Self-care of Heart Failure in Uganda

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426630
• Other study ID #: 2000025338
• Secondary ID: 1R21TW010998-01A
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: September 6, 2021

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• mHealth for heart failure patients in Uganda
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.

Locations

Country	Name	City	State
Uganda	Uganda Heart Institute	Kampala

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Fogarty International Center of the National Institute of Health, Makerere University, Uganda Heart Institute, University Health Network, Toronto

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	EQ-5D-5L, Mobility	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).	Baseline and Six-month follow-up visit
Secondary	EQ-5D-5L, Self-Care	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).	Baseline and Six-month follow-up visit
Secondary	EQ-5D-5L, Usual Activities	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).	Baseline and Six-month follow-up visit
Secondary	EQ-5D-5L, Pain or Discomfort	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).	Baseline and Six-month follow-up visit
Secondary	EQ-5D-5L, Anxiety or Depression	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).	Baseline and Six-month follow-up visit
Secondary	EQ-5D-5L, VAS	The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.	Baseline and Six-month follow-up visit
Secondary	Six-Minute Walk Test, Total Distance	Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.	Baseline and Six-month follow-up visit
Secondary	Left Ventricular Ejection Fraction	Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is <50%. High is >=50%. LVEF is measured by echocardiogram using Simpson biplane formula	Baseline and Six-month follow-up visit
Secondary	Frequency of Acute Care Visits	Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and =2. Possible range is 0-31.	Baseline and Six-month follow-up visit