Heart Failure
Conditions
Brief summary
The purpose of this study is to conduct a pilot study in 30 Heart Failure (HF) patients and visit companions (i.e., a family member who accompanies the patient to medical visits), to evaluate a pre- visit question/topic prompt list, designed to enhance patient and family member engagement during visits by providing a list of questions or topics that they may want to discuss with their health care provider.
Detailed description
Participants in this study will include 30 HF patients or dyads (i.e., a patient and family member who accompanies the patient into the examination room at a visit). While our study primarily will target HF dyads, if the investigators encounter recruitment difficulties, unaccompanied HF patients (i.e., HF patients who do not have a family member who can participate in the study with them) will also be enrolled. Procedures (methods): Single group pre-post study design. After providing informed consent, HF patients or dyads will receive the prompt list while in the waiting room prior to their visit. Completing the prompt list involves two steps. In step 1, participants will independently select from a predetermined list of questions (within topic areas) that they would like to ask their health care provider. The questions/topics were developed by other HF patients and family members in another phase of the study. Also, patients will be asked to choose behaviors they would like their family member to engage in during the visit (e.g., write down the provider's instructions, ask questions), from a structured list developed based on prior research. Family members will identify which behaviors they are willing to perform. In step 2, patients or dyads will collectively prioritize which questions/topics to discuss during the visit. Each dyad member will receive a prompt list to complete in the clinic waiting room immediately before their appointment. All visits will be audio-taped to assess effects of the intervention on communication behaviors during the visit. All participants will complete a questionnaire at baseline, 2 days after the audio-taped clinic visit, and at 3 months.
Interventions
BEHAVIORALQuestion/Topic Prompt List
A written document containing suggested questions that the family member and/or patient may want to ask the health care provider during the visit. A section is included for the patient to check which behaviors they would like for their family member to engage in during the visit and space is provided for the family member to check which behaviors they are willing to perform during the visit.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
RTI International
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Given the nature of the intervention and it's intended purpose (i.e., to enhance communication with participants and health care providers), it is not possible to blind participants, care providers, or the investigators.
Intervention model description
Individual patients and dyads (i.e., a HF patient and family member) will receive the question/topic prompt list immediately before their clinic visit
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Eligibility Criteria * Ambulatory adult patients ≥ 30 years old * Receive care in the University of North Carolina at Chapel Hill Cardiology practice * Have a clinical diagnosis of HF * Currently prescribed a loop diuretic * Have a New York Heart Association class II-IV * Must speak English * Have a working telephone or live with the patient Family Member Eligibility Criteria * ≥ 18 years old and able to give informed consent * Must be willing to participate in the intervention activities and provide informed consent * Must speak English * Have a working telephone or live with the patient Health Care Provider Eligibility Criteria * Must be an MD or advance practice provider (NP or PA) in the University of North Carolina at Chapel Hill Cardiology or General Internal Medicine practice * Must be willing to have an enrolled patient visit audio-taped
Exclusion criteria
For patients: * blindness, * terminal illness with life expectancy \<1 year (based on physician estimation), * currently on or anticipated to start dialysis within 1 year, * oxygen dependent chronic obstructive pulmonary disease, * residency in a nursing home, or * psychiatric illness that would interfere with protocol completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Eligible Participants Who Enroll | 6 months | The investigators will assess enrollment success into the study among those considered eligible. Investigators aim to have at least 50% of eligible participants enroll into the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | Up to 1 month after clinic visit | The SCHFI was used to measure self-care management. The 10-item self-care management scale assesses decision-making in response to HF symptoms. Of note, the self-care management questions are answered and scored only if the respondent endorses having experienced dyspnea or ankle swelling within the past month.The subscale score is standardized, with scores ranging from 0-100 (higher scores indicate greater self-care management). Scores ≥ 70 are reflective of adequate self-care management. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | Up to 1 month after clinic visit | The SCHFI was used to measure self-care maintenance. The 10-item self-care maintenance scale assesses behaviors used to maintain physiologic stability (e.g., adherence to medications, frequent weighing).This subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care maintenance). Scores ≥ 70 are reflective of adequate self-care maintenance. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | Up to 1 month after | The 6-item subscale of the SCHFI was used to assess self-confidence in performing behaviors and making decisions to control heart failure symptoms. The subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care confidence). Scores ≥ 70 are reflective of adequate self-care confidence. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale | Up to 1 month after. | The CC-SCHFI is a 22-item measure (across 3 sub-scales) that was used to assess the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 6-item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher confidence in ability to contribute to the patient's self-care. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Acceptability Checklist Score | Within 2 days after receiving checklist | The investigators will assess the perceived value of the checklist using a series of 11 questions developed for this study. Each question is scored using a 6-point Likert response scale where 1 = strongly disagree and 6 = strongly agree. Higher scores mean higher perceived value of the checklist. |
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale | Up to 1 month after | The CC-SCHFI is a 22-item measure (across 3 sub-scales) that assesses the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 6-item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher contribution to the patient's self-care management. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | Up to 1 month after clinic visit | The PEPPI is a 6-item measure which assesses confidence (self-efficacy) in communicating with health care providers. Each question is scored using a 5-point likert scale (0= not at all confident to 5=very confident). Higher scores indicate greater confidence in communicating with health care providers. Measured at Baseline, 2-Day Follow-Up, and during the 1 Month Follow-Up. |
| Mean Score on Communication With Physicians Measure | Up to 1 month after clinic visit | The Communication with Physicians measure by Lorig was used. It is a 3-item measure assessing the frequency of patients' engagement in communication behaviors during medical visits, including, preparing a list of questions, asking questions about treatment, and discussing personal problems with provider. Each question is answered using a 6-point Likert scale ranging from 0=never to 5=always. Higher scores indicate more active engagement in communication during medical visits. Measured at Baseline and during the 1 Month Follow-Up. |
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale | Up to 1 month after | The CC-SCHFI is a 22-item measure (across 3 sub-scales) that assesses the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 10- item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher contribution to self-care maintenance. Measured at Baseline and during the 1 Month Follow-Up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Accompanied Patients The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor. | 23 |
| Companions Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient. | 23 |
| Unaccompanied Patients The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. | 7 |
| Total | 53 |
Baseline characteristics
| Characteristic | Accompanied Patients | Companions | Unaccompanied Patients | Total |
|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 13.9 | 58.6 years STANDARD_DEVIATION 16 | 61.1 years STANDARD_DEVIATION 17.2 | 59.9 years STANDARD_DEVIATION 3.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 23 Participants | 6 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Mean Score on Communication With Physicians Measure | 3.35 units on a scale STANDARD_DEVIATION 1.31 | — | 3.00 units on a scale STANDARD_DEVIATION 1.66 | 3.27 units on a scale STANDARD_DEVIATION 1.4 |
| Mean Score on the CC-SCHFI - Confidence Subscale | — | 68.24 units on a scale STANDARD_DEVIATION 25.98 | — | 68.24 units on a scale STANDARD_DEVIATION 25.98 |
| Mean Score on the CC-SCHFI - Maintenance Subscale | — | 57.72 units on a scale STANDARD_DEVIATION 23.37 | — | 57.72 units on a scale STANDARD_DEVIATION 23.37 |
| Mean Score on the CC-SCHFI - Management Subscale | — | 75.56 units on a scale STANDARD_DEVIATION 14.46 | — | 75.56 units on a scale STANDARD_DEVIATION 14.46 |
| Mean Score on the PEPPI | 3.68 units on a scale STANDARD_DEVIATION 0.32 | 3.83 units on a scale STANDARD_DEVIATION 0.31 | 3.52 units on a scale STANDARD_DEVIATION 0.56 | 3.72 units on a scale STANDARD_DEVIATION 0.38 |
| Mean Score on the SCHFI - Confidence Subscale | 67.48 units on a scale STANDARD_DEVIATION 19.44 | — | 60.23 units on a scale STANDARD_DEVIATION 12.39 | 65.93 units on a scale STANDARD_DEVIATION 18.4 |
| Mean Score on the SCHFI - Maintenance Subscale | 76.20 units on a scale STANDARD_DEVIATION 9.72 | — | 81.10 units on a scale STANDARD_DEVIATION 12.76 | 77.25 units on a scale STANDARD_DEVIATION 10.64 |
| Mean Score on the SCHFI - Management Subscale | 69.17 units on a scale STANDARD_DEVIATION 14.43 | — | 66.25 units on a scale STANDARD_DEVIATION 6.29 | 68.44 units on a scale STANDARD_DEVIATION 12.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 11 Participants | 1 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 12 Participants | 6 Participants | 29 Participants |
| Region of Enrollment United States | 23 Participants | 23 Participants | 7 Participants | 53 Participants |
| Sex: Female, Male Female | 6 Participants | 19 Participants | 5 Participants | 30 Participants |
| Sex: Female, Male Male | 17 Participants | 4 Participants | 2 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percent of Eligible Participants Who Enroll
The investigators will assess enrollment success into the study among those considered eligible. Investigators aim to have at least 50% of eligible participants enroll into the trial.
Time frame: 6 months
Population: Includes all participants screened for enrollment into the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient and Companions | Percent of Eligible Participants Who Enroll | 44 percentage of participants |
Secondary
Mean Acceptability Checklist Score
The investigators will assess the perceived value of the checklist using a series of 11 questions developed for this study. Each question is scored using a 6-point Likert response scale where 1 = strongly disagree and 6 = strongly agree. Higher scores mean higher perceived value of the checklist.
Time frame: Within 2 days after receiving checklist
Population: Data were reported when present and applicable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Acceptability Checklist Score | Easy to fill out | 5.86 score on a scale | Standard Deviation 0.35 |
| Patient and Companions | Mean Acceptability Checklist Score | Adequate time in waiting room to finish checklist | 5.48 score on a scale | Standard Deviation 1.2 |
| Patient and Companions | Mean Acceptability Checklist Score | Instructions clear and understandable | 5.95 score on a scale | Standard Deviation 0.21 |
| Patient and Companions | Mean Acceptability Checklist Score | Clearer understanding of companion's concerns | 4.75 score on a scale | Standard Deviation 1.94 |
| Patient and Companions | Mean Acceptability Checklist Score | Easier to talk to doctor | 5.09 score on a scale | Standard Deviation 1.16 |
| Patient and Companions | Mean Acceptability Checklist Score | Easy to use during discussion with Dr | 5.89 score on a scale | Standard Deviation 0.32 |
| Patient and Companions | Mean Acceptability Checklist Score | Felt supported by companion due to checklist | 5.25 score on a scale | Standard Deviation 1.52 |
| Patient and Companions | Mean Acceptability Checklist Score | Existing questions matched what I wanted to ask | 5.35 score on a scale | Standard Deviation 1.3 |
| Patient and Companions | Mean Acceptability Checklist Score | Would use checklist at next appt | 5.00 score on a scale | Standard Deviation 1.75 |
| Patient and Companions | Mean Acceptability Checklist Score | Able to learn more from Dr using checklist | 5.28 score on a scale | Standard Deviation 1.36 |
| Patient and Companions | Mean Acceptability Checklist Score | Checklist helped to get more questions asked | 5.39 score on a scale | Standard Deviation 1.34 |
| Companions | Mean Acceptability Checklist Score | Would use checklist at next appt | 5.12 score on a scale | Standard Deviation 1.58 |
| Companions | Mean Acceptability Checklist Score | Able to learn more from Dr using checklist | 5.24 score on a scale | Standard Deviation 1.39 |
| Companions | Mean Acceptability Checklist Score | Clearer understanding of companion's concerns | 5.53 score on a scale | Standard Deviation 1.23 |
| Companions | Mean Acceptability Checklist Score | Adequate time in waiting room to finish checklist | 5.52 score on a scale | Standard Deviation 1.2 |
| Companions | Mean Acceptability Checklist Score | Easier to talk to doctor | 5.04 score on a scale | Standard Deviation 1.36 |
| Companions | Mean Acceptability Checklist Score | Easy to fill out | 5.95 score on a scale | Standard Deviation 0.21 |
| Companions | Mean Acceptability Checklist Score | Instructions clear and understandable | 5.91 score on a scale | Standard Deviation 0.29 |
| Companions | Mean Acceptability Checklist Score | Checklist helped to get more questions asked | 5.35 score on a scale | Standard Deviation 1.27 |
| Companions | Mean Acceptability Checklist Score | Easy to use during discussion with Dr | 5.94 score on a scale | Standard Deviation 0.24 |
| Companions | Mean Acceptability Checklist Score | Existing questions matched what I wanted to ask | 5.13 score on a scale | Standard Deviation 1.42 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Instructions clear and understandable | 5.29 score on a scale | Standard Deviation 1.89 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Easier to talk to doctor | 4.86 score on a scale | Standard Deviation 1.46 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Existing questions matched what I wanted to ask | 5.14 score on a scale | Standard Deviation 0.69 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Adequate time in waiting room to finish checklist | 5.29 score on a scale | Standard Deviation 1.89 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Easy to fill out | 6.00 score on a scale | Standard Deviation 0 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Easy to use during discussion with Dr | 5.50 score on a scale | Standard Deviation 1.23 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Would use checklist at next appt | 4.33 score on a scale | Standard Deviation 1.86 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Checklist helped to get more questions asked | 4.83 score on a scale | Standard Deviation 1.6 |
| Unaccompanied Patients | Mean Acceptability Checklist Score | Able to learn more from Dr using checklist | 4.50 score on a scale | Standard Deviation 1.64 |
Secondary
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale
The CC-SCHFI is a 22-item measure (across 3 sub-scales) that was used to assess the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 6-item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher confidence in ability to contribute to the patient's self-care. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after.
Population: This measure is completed by Companions only. Data are missing for 1 Companion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale | Baseline | 68.24 score on a scale | Standard Deviation 25.98 |
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale | 1 Month Follow-Up | 73.29 score on a scale | Standard Deviation 22.02 |
p-value: 0.21t-test, 2 sided
Secondary
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale
The CC-SCHFI is a 22-item measure (across 3 sub-scales) that assesses the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 10- item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher contribution to self-care maintenance. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after
Population: This measure is completed by Companions only. Patient responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Companion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale | Baseline | 57.72 score on a scale | Standard Deviation 23.37 |
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale | 1 Month Follow-Up | 57.42 score on a scale | Standard Deviation 26.18 |
p-value: 0.95t-test, 2 sided
Secondary
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale
The CC-SCHFI is a 22-item measure (across 3 sub-scales) that assesses the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. This 6-item subscale uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher contribution to the patient's self-care management. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after
Population: This measure is completed by Companions only. Accompanied and Unaccompanied responses are not applicable here and are captured in a separate outcome measure. Data are missing for 14 Companions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale | 1 Month Follow-Up | 72.22 score on a scale | Standard Deviation 14.81 |
| Companions | Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale | Baseline | 75.56 score on a scale | Standard Deviation 14.46 |
p-value: 0.52t-test, 2 sided
Secondary
Mean Score on Communication With Physicians Measure
The Communication with Physicians measure by Lorig was used. It is a 3-item measure assessing the frequency of patients' engagement in communication behaviors during medical visits, including, preparing a list of questions, asking questions about treatment, and discussing personal problems with provider. Each question is answered using a 6-point Likert scale ranging from 0=never to 5=always. Higher scores indicate more active engagement in communication during medical visits. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after clinic visit
Population: This measure was only answered by patients. Companion responses are not applicable here. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Score on Communication With Physicians Measure | Baseline | 3.35 score on a scale | Standard Deviation 1.31 |
| Patient and Companions | Mean Score on Communication With Physicians Measure | 1 Month Follow-Up | 3.45 score on a scale | Standard Deviation 0.99 |
| Unaccompanied Patients | Mean Score on Communication With Physicians Measure | Baseline | 3.00 score on a scale | Standard Deviation 1.66 |
| Unaccompanied Patients | Mean Score on Communication With Physicians Measure | 1 Month Follow-Up | 2.72 score on a scale | Standard Deviation 0.98 |
p-value: 0.6t-test, 2 sided
p-value: 0.4t-test, 2 sided
Secondary
Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)
The PEPPI is a 6-item measure which assesses confidence (self-efficacy) in communicating with health care providers. Each question is scored using a 5-point likert scale (0= not at all confident to 5=very confident). Higher scores indicate greater confidence in communicating with health care providers. Measured at Baseline, 2-Day Follow-Up, and during the 1 Month Follow-Up.
Time frame: Up to 1 month after clinic visit
Population: Reported data are less than the total number of participants who completed each arm due to participants not responding to questions for this measure. Data are missing for 1 Accompanied, 1 Unaccompanied, and 1 Companion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | Baseline | 3.68 score on a scale | Standard Deviation 0.32 |
| Patient and Companions | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | 1 Month Follow-Up | 3.76 score on a scale | Standard Deviation 0.29 |
| Companions | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | Baseline | 3.83 score on a scale | Standard Deviation 0.31 |
| Companions | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | 1 Month Follow-Up | 3.81 score on a scale | Standard Deviation 0.33 |
| Unaccompanied Patients | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | Baseline | 3.52 score on a scale | Standard Deviation 0.56 |
| Unaccompanied Patients | Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | 1 Month Follow-Up | 3.78 score on a scale | Standard Deviation 0.39 |
p-value: 0.23t-test, 2 sided
p-value: 0.67t-test, 2 sided
p-value: 0.054t-test, 2 sided
Secondary
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale
The SCHFI was used to measure self-care maintenance. The 10-item self-care maintenance scale assesses behaviors used to maintain physiologic stability (e.g., adherence to medications, frequent weighing).This subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care maintenance). Scores ≥ 70 are reflective of adequate self-care maintenance. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after clinic visit
Population: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | Baseline | 76.20 score on a scale | Standard Deviation 9.72 |
| Patient and Companions | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | 1 Month Follow-Up | 76.51 score on a scale | Standard Deviation 12.7 |
| Unaccompanied Patients | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | Baseline | 81.10 score on a scale | Standard Deviation 12.76 |
| Unaccompanied Patients | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | 1 Month Follow-Up | 76.66 score on a scale | Standard Deviation 9.43 |
p-value: 0.9t-test, 2 sided
p-value: 0.3t-test, 2 sided
Secondary
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale
The SCHFI was used to measure self-care management. The 10-item self-care management scale assesses decision-making in response to HF symptoms. Of note, the self-care management questions are answered and scored only if the respondent endorses having experienced dyspnea or ankle swelling within the past month.The subscale score is standardized, with scores ranging from 0-100 (higher scores indicate greater self-care management). Scores ≥ 70 are reflective of adequate self-care management. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after clinic visit
Population: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | Baseline | 69.17 score on a scale | Standard Deviation 14.43 |
| Patient and Companions | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | 1 Month Follow-Up | 61.67 score on a scale | Standard Deviation 31.72 |
| Unaccompanied Patients | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | Baseline | 66.25 score on a scale | Standard Deviation 6.29 |
| Unaccompanied Patients | Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | 1 Month Follow-Up | 62.50 score on a scale | Standard Deviation 6.45 |
p-value: 0.3t-test, 2 sided
Secondary
Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale
The 6-item subscale of the SCHFI was used to assess self-confidence in performing behaviors and making decisions to control heart failure symptoms. The subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care confidence). Scores ≥ 70 are reflective of adequate self-care confidence. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up.
Time frame: Up to 1 month after
Population: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient and Companions | Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | Baseline | 67.48 score on a scale | Standard Deviation 19.44 |
| Patient and Companions | Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | 1 Month Follow-Up | 70.51 score on a scale | Standard Deviation 15.67 |
| Unaccompanied Patients | Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | Baseline | 60.23 score on a scale | Standard Deviation 12.39 |
| Unaccompanied Patients | Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | 1 Month Follow-Up | 61.16 score on a scale | Standard Deviation 13.16 |
p-value: 0.4t-test, 2 sided
p-value: 0.85t-test, 2 sided