Heart Failure
Conditions
Brief summary
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it.
Detailed description
An estimated 6.5 million adults in the U.S. have Heart Failure (HF) and the prevalence is increasing. HF is characterized by poor quality of life but this is amenable to self-management. However, the amount of support available from providers to help manage complications is far beyond what is feasible. The complex needs of these patients require a new vision for delivery of health care services, such as an mHealth management model. mHealth technologies such as blue-tooth enabled BP, heart rate, weight, and pulse oximetry remote monitoring permit sharing of immediate biometric data and video messages with providers and instantaneous feedback to patients before symptom crises, that is, when and where patients need it. This is a single-blinded comparative effectiveness randomized controlled trial conducted in a real-world setting. A sample of 400 dyads, that is older patients with HF (\>55 years) and their caregivers, will be recruited from a large medical center and randomly assigned to one of two arms: 200 dyads to a provider-directed model or 200 dyads to the mHealth management model. The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The standard of care will be augmented by providing home equipment kits with weight scale, blood pressure, pulse oximetry devices and a Log to record data. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols. Outcomes informed a prior by community stakeholders to be most important at the patient, caregiver, and health systems-levels will be collected and compared at baseline, 3- and 6- months: 1) For the patient: self-care of HF; confidence and self-efficacy to manage care, symptoms, medications and treatments; HF knowledge; mental and physical health, health distress, informational support, equipment usability, and quality of life. 2) For the caregiver: caregiver burden and health. 3) For the Health System: patient satisfaction, hospital, emergency & provider visits, and mortality. Differential benefits for subsets of participants will be evaluated according to patient characteristics (socio-demographical, rurality, etc.). Evaluation of mediation variables will enhance our understanding of underlying processes. This research has the potential to revolutionize care for high-cost and high-need patients such as those with HF.
Interventions
OTHERProvider-Based Care Model Arm
The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
BEHAVIORALmHealth Model Arm
The PI will provide each patient with weight scale, blood pressure cuff, & pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
Sponsors
Patient-Centered Outcomes Research Institute
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
The provider-directed management model is the current care standard for patients with HF; care delivery consists of office and emergency visits, with telephone or in person communications. The mHealth care management model consists of real time bio-monitoring kits and telemedicine visits using a secure wireless gateway with a cloud-based clinician portal connected to a Bluetooth-paired Android Tablet. Daily readings are transmitted to a 24-hour RN call center and triaged per protocols.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged \> 55 years with HF (documented in medical record). * Has capacity to understand informed consent. * Able to stand (briefly) without assistance. * Has a designated caregiver. * Agrees to be followed (treated) by UAMS physician/provider for 6 months after discharge.
Exclusion criteria
* Speaks a language other than English or Spanish. * Active psychosis or other severe cognitive disorder that interferes with capacity to understand and comply with study procedures. * A history of drug or alcohol abuse in the past 90 days (documented in medical record).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Care of Heart Failure Maintenance Scale (SCHFI) | Change from Baseline, 3 months, and 6 months | self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Promis 43v2.1 Health Profile Pain Interference 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures pain. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 41.1-76.3 |
| Promis 43v2.1 Health Profile Sleep Disturbance 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures sleep disturbance. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population Min/Max Range 31.7-76.1 |
| Promis 43v2.1 Health Profile Ability to Participate in Social Roles and Activities 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures the ability to participate in social roles and activities . Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max Range 26.7-65 |
| Promis 43v2.1 Health Profile PROMIS Pain Intensity Item (Global07) | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures pain intensite. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 0-10 |
| Medical Outcomes Study MOS Health Distress Scale | Change from Baseline, 3 months, and 6 months | questionnaire assesses psychological impact/health distress |
| Minnesota Living With Heart Failure Questionnaire (MLHFQ) | Change from Baseline to 6 months | questionnaire to assess quality of life. Scoring for the MLHFQ ranges from 0 to 105, the higher the score the more affected, over the past 4 months, the individual is by their heart failure. |
| Promis 43v2.1 Health Profile Anxiety 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures anxiety. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/max range is 39.1-82.7 |
| Promis 43v2.1 Health Profile Depression 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures depression. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 38.4-80.3 |
| Promis 43v2.1 Health Profile Fatigue 6a | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures fatigue. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 33.4-76.8 |
| Promis 43v2.1 Health Profile Physical Function 6b | Change from Baseline, 3 months, and 6 months | subscale of questionnaire that measures physical function. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 21.6-58.7 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ-8) | Change from baseline to 3 months and 6 months | questionnaire to Assess patient's satisfaction with care received |
| Treatment Visits | Change from baseline to 3 months and 6 months | number of medical treatment visits |
| Mortality | 3 months and 6 months | death |
| Optum SF36v2 Health Survey | Change from baseline to 6 months | questionnaire to Assess caregiver health |
| Zarit Caregiver Burden Scale | Change from baseline to 6 months | questionnaire to Assess caregiver perception of burden. Scoring of the Zarit Burden Interview ranges from 0-88, the higher the score, the more severe the burden on the caregiver. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled and assessed in the study are HF patients. Caregivers were not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Provider-Based Care Model Arm Non-connected home vital sign equipment will be given to patients in this group. The patients in the group will be instructed to record their daily readings on a paper log provided by the research team. These monitoring devices will not transmit readings to a centralized location and no one will be alerted to out-of-range readings or compliance with taking daily vital sign measures. At the front page of the log, normal ranges will be described with brief instructions about what participants/caregivers should do if their readings are out-of-range. Logs will be collected at baseline, 3-months and 6-months.
Provider-Based Care Model Arm: The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures. | 12 |
| mHealth Model Arm Connected home vital sign equipment (mHealth) will be given to patients in this group. The patients will be instructed to take their daily readings, which will automatically be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse (RN) Call Center will be automatically alerted and the event will be triaged. Daily measures and medical follow-up from the measures will be counted and collected at baseline, 3-months, and 6-months.
mHealth Model Arm: The PI will provide each patient with weight scale, blood pressure cuff, & pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged. | 14 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Due to the pandemic in person visits were not allowed | 4 | 2 |
Baseline characteristics
| Characteristic | mHealth Model Arm | Total | Provider-Based Care Model Arm |
|---|---|---|---|
| Age, Continuous | 64.67 years STANDARD_DEVIATION 8.89 | 63.60 years STANDARD_DEVIATION 7.73 | 62 years STANDARD_DEVIATION 6.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
Self-Care of Heart Failure Maintenance Scale (SCHFI)
self care scores on a scale range from 70 to 100, mean (SD). The SCHFI uses a Likert-type scale, with responses ranging from 1 (never) to 5 (always). The SCHFI also includes scales for self-care management and self-care confidence. Higher scores on the SCHFI indicate better self-care. A score of less than 70 on any of the subscales is considered inadequate self-care.
Time frame: Change from Baseline, 3 months, and 6 months
Population: The study was terminated by mutual agreement by the funding agency and UAMS due to circumstances of the pandemic which made it impossible to recruit patients in the hospital and their caregivers were not allowed in the hospital setting.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Provider-Based Care Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | Baseline | 75.50 score on a scale | Standard Deviation 14.55 |
| Provider-Based Care Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | 3 Month | 80.00 score on a scale | Standard Deviation 8.72 |
| Provider-Based Care Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | 6 Month | 83.50 score on a scale | Standard Deviation 3.42 |
| mHealth Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | Baseline | 83.67 score on a scale | Standard Deviation 13.41 |
| mHealth Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | 3 Month | 99 score on a scale | Standard Deviation 1.41 |
| mHealth Model Arm | Self-Care of Heart Failure Maintenance Scale (SCHFI) | 6 Month | 74.67 score on a scale | Standard Deviation 21.39 |
Secondary
Medical Outcomes Study MOS Health Distress Scale
questionnaire assesses psychological impact/health distress
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
questionnaire to assess quality of life. Scoring for the MLHFQ ranges from 0 to 105, the higher the score the more affected, over the past 4 months, the individual is by their heart failure.
Time frame: Change from Baseline to 6 months
Secondary
Promis 43v2.1 Health Profile Ability to Participate in Social Roles and Activities 6a
subscale of questionnaire that measures the ability to participate in social roles and activities . Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max Range 26.7-65
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Anxiety 6a
subscale of questionnaire that measures anxiety. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/max range is 39.1-82.7
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Depression 6a
subscale of questionnaire that measures depression. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 38.4-80.3
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Fatigue 6a
subscale of questionnaire that measures fatigue. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 33.4-76.8
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Pain Interference 6a
subscale of questionnaire that measures pain. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 41.1-76.3
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Physical Function 6b
subscale of questionnaire that measures physical function. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 21.6-58.7
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile PROMIS Pain Intensity Item (Global07)
subscale of questionnaire that measures pain intensite. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population. Min/Max range 0-10
Time frame: Change from Baseline, 3 months, and 6 months
Secondary
Promis 43v2.1 Health Profile Sleep Disturbance 6a
subscale of questionnaire that measures sleep disturbance. Scoring for this PROMIS instrument uses Item Response Theory (IRT), a family of statistical models that link individual items to a presumed underlying trait or concept represented by all items in the item bank. Score of 50 on any domain is the average. Greater than 50 likely represents somewhat sicker people than the general population Min/Max Range 31.7-76.1
Time frame: Change from Baseline, 3 months, and 6 months
Other Pre-specified
Client Satisfaction Questionnaire (CSQ-8)
questionnaire to Assess patient's satisfaction with care received
Time frame: Change from baseline to 3 months and 6 months
Other Pre-specified
Mortality
death
Time frame: 3 months and 6 months
Other Pre-specified
Optum SF36v2 Health Survey
questionnaire to Assess caregiver health
Time frame: Change from baseline to 6 months
Other Pre-specified
Treatment Visits
number of medical treatment visits
Time frame: Change from baseline to 3 months and 6 months
Other Pre-specified
Zarit Caregiver Burden Scale
questionnaire to Assess caregiver perception of burden. Scoring of the Zarit Burden Interview ranges from 0-88, the higher the score, the more severe the burden on the caregiver.
Time frame: Change from baseline to 6 months