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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| RTI International | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Question/Topic Prompt List | Other | The Question/Topic Prompt List is provided to HF Patients and their family member (if applicable) for completion prior to being seen by the doctor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Question/Topic Prompt List | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 2 days after receiving checklist |
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Inclusion Criteria:
Patient Eligibility Criteria
Family Member Eligibility Criteria
Health Care Provider Eligibility Criteria
Exclusion Criteria:
For patients:
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| Name | Affiliation | Role |
|---|---|---|
| Crystal Wiley Cené, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Companions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2019 |
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Individual patients and dyads (i.e., a HF patient and family member) will receive the question/topic prompt list immediately before their clinic visit
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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.
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| 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. | Up to 1 month after clinic visit |
| 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. | Up to 1 month after clinic visit |
| 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. | Up to 1 month after |
| 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. | Up to 1 month after. |
| 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. | Up to 1 month after |
| 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. | Up to 1 month after |
| 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. | Up to 1 month after clinic visit |
| 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. | Up to 1 month after clinic visit |
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
| FG002 | Unaccompanied Patients | The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Companions | Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient. |
| BG002 | Unaccompanied Patients | The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mean Score on the SCHFI - Maintenance Subscale | The Self-Care of Heart Failure Index (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 confidence). 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 | This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and 23 Companions | Mean | Standard Deviation | units on a scale |
| ||||||||
| Mean Score on the 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. 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 indicates 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. | This measure is completed by Accompanied and Unaccompanied patients only. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients and all companions | Mean | Standard Deviation | units on a scale |
| ||||||||
| Mean Score on the SCHFI - Confidence Subscale | The SCHFI 6-item subscale of the SCHFI assessed 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. | This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and all companions. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Mean Score on the CC-SCHFI - Maintenance Subscale | The Caregiver Contribution to Self-Care of Heart Failure Index (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. | This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Mean Score on the 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. | This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Mean Score on the CC-SCHFI - Confidence 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 confidence in their ability to contribute to the patient's self-care. | This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients. | Mean | Standard Deviation | units on a scale |
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| Mean Score on the PEPPI | The Perceived Efficacy in Patient-Physician Interactions (PEPPI) measure, a 6-item measure assessed 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. | Row total differs from overall total due to missing data on the questionnaire | Mean | Standard Deviation | units on a scale |
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| Mean Score on Communication With Physicians Measure | The Communication with Physicians measure is a 3-item measure which assesses 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. | The Communication with Physicians measure was not completed by companions. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes all participants screened for enrollment into the study | Posted | Number | percentage of participants | 6 months |
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| 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. | Data were reported when present and applicable. | Posted | Mean | Standard Deviation | score on a scale | Within 2 days after receiving checklist |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after clinic visit |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after clinic visit |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after |
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| 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. | This measure is completed by Companions only. Data are missing for 1 Companion | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after. |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after clinic visit |
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| 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. | This measure was only answered by patients. Companion responses are not applicable here. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month after clinic visit |
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Not applicable as safety data were not collected during the study
Safety data were not planned to be collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Companions | Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Unaccompanied Patients | The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Wiley Cené, MD, MPH, FAHA | University of North Carolina at Chapel Hill | 919-445-6783 | crystal_cene@med.unc.edu |
| Jul 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OG002 | Unaccompanied Patients | The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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| Unaccompanied Patients |
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
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The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor. |
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The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
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