Heart Failure
Conditions
Keywords
Heart Failure, Telemedicine, Uganda, mHealth, Implementation Science
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.
Interventions
OTHERmHealth 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.
Sponsors
Fogarty International Center of the National Institute of Health
Makerere University
Uganda Heart Institute
University Health Network, Toronto
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Care for Heart Failure Index, Maintenance | Baseline and Six-month follow-up | 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. |
| Self-Care for Heart Failure Index, Management | Baseline and Six-month follow-up | 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. |
| Self-Care for Heart Failure Index, Confidence | Baseline and Six-month follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L, Pain or Discomfort | Baseline and Six-month follow-up visit | 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). |
| EQ-5D-5L, Anxiety or Depression | Baseline and Six-month follow-up visit | 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). |
| EQ-5D-5L, VAS | Baseline and Six-month follow-up visit | 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'. |
| EQ-5D-5L, Mobility | Baseline and Six-month follow-up visit | 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). |
| Left Ventricular Ejection Fraction | Baseline and Six-month follow-up visit | 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 |
| Frequency of Acute Care Visits | Baseline and Six-month follow-up visit | 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. |
| Six-Minute Walk Test, Total Distance | Baseline and Six-month follow-up visit | 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. |
| EQ-5D-5L, Self-Care | Baseline and Six-month follow-up visit | 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). |
| EQ-5D-5L, Usual Activities | Baseline and Six-month follow-up visit | 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). |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mHealth Heart failure patients enrolled in the mHealth program
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. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | mHealth |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 53.0 years |
| Healthcare Quality of Life: EQ-5D Anxiety or Depression Having Problems | 28 Participants |
| Healthcare Quality of Life: EQ-5D Anxiety or Depression No Problem | 44 Participants |
| Healthcare Quality of Life: EQ-5D Mobility Having Problems | 25 Participants |
| Healthcare Quality of Life: EQ-5D Mobility No Problem | 47 Participants |
| Healthcare Quality of Life: EQ-5D Pain or Discomfort Having Problems | 30 Participants |
| Healthcare Quality of Life: EQ-5D Pain or Discomfort No Problem | 42 Participants |
| Healthcare Quality of Life: EQ-5D Self-Care Having Problems | 30 Participants |
| Healthcare Quality of Life: EQ-5D Self-Care No Problem | 42 Participants |
| Healthcare Quality of Life: EQ-5D Usual Activities Having Problems | 39 Participants |
| Healthcare Quality of Life: EQ-5D Usual Activities No Problem | 33 Participants |
| Health Quality of Life: EQ VAS | 70 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 72 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Uganda | 72 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 72 |
| other Total, other adverse events | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
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
Time frame: Baseline and Six-month follow-up
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | Self-Care for Heart Failure Index, Confidence | Baseline | 41.2 score on a scale |
| mHealth | Self-Care for Heart Failure Index, Confidence | Six-month | 97.1 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and Six-month follow-up
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | Self-Care for Heart Failure Index, Maintenance | Baseline | 35 score on a scale |
| mHealth | Self-Care for Heart Failure Index, Maintenance | Six-month | 85 score on a scale |
Comparison: Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and Six-month follow-up
Population: The management sub-scale only score if the patient acknowledged having trouble breathing or ankle swelling in the past interval.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | Self-Care for Heart Failure Index, Management | Baseline | 20 score on a scale |
| mHealth | Self-Care for Heart Failure Index, Management | Six-month | 85 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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).
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | EQ-5D-5L, Anxiety or Depression | Baseline | No problems | 44 Participants |
| mHealth | EQ-5D-5L, Anxiety or Depression | Baseline | Having problems | 28 Participants |
| mHealth | EQ-5D-5L, Anxiety or Depression | Six-month | No problems | 57 Participants |
| mHealth | EQ-5D-5L, Anxiety or Depression | Six-month | Having problems | 9 Participants |
p-value: <0.001Chi-squared
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).
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | EQ-5D-5L, Mobility | Baseline | No Problems | 47 Participants |
| mHealth | EQ-5D-5L, Mobility | Baseline | Having Problems | 25 Participants |
| mHealth | EQ-5D-5L, Mobility | Six-month | No Problems | 54 Participants |
| mHealth | EQ-5D-5L, Mobility | Six-month | Having Problems | 12 Participants |
Comparison: Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.p-value: 0.028Chi-squared
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).
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | EQ-5D-5L, Pain or Discomfort | Baseline | No problems | 42 Participants |
| mHealth | EQ-5D-5L, Pain or Discomfort | Baseline | Having problems | 30 Participants |
| mHealth | EQ-5D-5L, Pain or Discomfort | Six-month | No problems | 45 Participants |
| mHealth | EQ-5D-5L, Pain or Discomfort | Six-month | Having problems | 21 Participants |
p-value: 0.23Chi-squared
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).
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | EQ-5D-5L, Self-Care | Baseline | No problems | 42 Participants |
| mHealth | EQ-5D-5L, Self-Care | Baseline | Having problems | 30 Participants |
| mHealth | EQ-5D-5L, Self-Care | Six-month | No problems | 58 Participants |
| mHealth | EQ-5D-5L, Self-Care | Six-month | Having problems | 8 Participants |
p-value: <0.001Chi-squared
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).
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | EQ-5D-5L, Usual Activities | Baseline | No problems | 33 Participants |
| mHealth | EQ-5D-5L, Usual Activities | Baseline | Having problems | 39 Participants |
| mHealth | EQ-5D-5L, Usual Activities | Six-month | No problems | 54 Participants |
| mHealth | EQ-5D-5L, Usual Activities | Six-month | Having problems | 12 Participants |
p-value: <0.001Chi-squared
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'.
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | EQ-5D-5L, VAS | Baseline | 70 score on the visual analogue scale |
| mHealth | EQ-5D-5L, VAS | Six-month | 80 score on the visual analogue scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| mHealth | Frequency of Acute Care Visits | Baseline | 0 | 56 Participants |
| mHealth | Frequency of Acute Care Visits | Baseline | 1 | 12 Participants |
| mHealth | Frequency of Acute Care Visits | Baseline | ≥2 | 4 Participants |
| mHealth | Frequency of Acute Care Visits | Six-month | 0 | 60 Participants |
| mHealth | Frequency of Acute Care Visits | Six-month | 1 | 6 Participants |
| mHealth | Frequency of Acute Care Visits | Six-month | ≥2 | 0 Participants |
p-value: <0.001Chi-squared
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
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | Left Ventricular Ejection Fraction | Baseline | 30 Percentage of Left Ventricular Ejection |
| mHealth | Left Ventricular Ejection Fraction | Six-month | 33.0 Percentage of Left Ventricular Ejection |
p-value: 0.07Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline and Six-month follow-up visit
Population: 6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| mHealth | Six-Minute Walk Test, Total Distance | Baseline | 320.3 Meters |
| mHealth | Six-Minute Walk Test, Total Distance | Six-month | 340.0 Meters |
p-value: <0.001Wilcoxon (Mann-Whitney)