HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
HFpEF, CHAT, Conversations Helpful for Awareness of Illness Trajectory, Effectiveness-Implementation Trial, Heart Failure with Preserved Ejection Fraction
Brief summary
The researchers are studying whether an intervention that involves video-based educational content and a health coach is acceptable, feasible, and effective for people with Heart Failure with Preserved Ejection Fraction (HFpEF).
Detailed description
This is a pilot randomized controlled trial of 50 subjects that will compare the CHAT intervention (video-based educational content and a health coach) with usual care. Video-based educational content was developed based on Adult Learning Theory and Social Cognitive Theory. Key content areas covered by the videos and health coach will include: HFpEF Overview, Signs and Symptoms of HFpEF, Medication Management, Physical Activity and Diet with HFpEF, and Planning for the Future (Advance Care Planning).
Interventions
BEHAVIORALConversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention
The Conversations Helpful for Awareness of illness Trajectory (CHAT) intervention will incorporate 4 health-coach sessions, supplemented by 7 educational videos. Each session will be up to 60 minutes long and will be conducted remotely. During the health coach sessions, a trained health coach will work with subjects, reviewing the content of each video and emphasizing key learning content.
BEHAVIORALStandard of Care (SOC)
The Standard of Care Group will not have access to the Health Coach or video-based educational content. This group will have no study activities during Weeks 1-7 but will participate in follow-up assessments.
Sponsors
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female ≥ 60 years old 2. Documentation of HFpEF according to clinical practice guidelines
Exclusion criteria
1. Previously referred to hospice care 2. Prior completion of advance directives; forms uploaded to the EMR in the past 3 years 3. Moderate-severe dementia or psychiatric disorder precluding informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days | Baseline, 90 days | This measure uses the SCHFI, a 29-item survey that evaluates three subscales: Symptom Perception, Self-Care Management, and Self-Care Maintenance, with the lowest possible score of 0 and the highest possible score of 100. Higher scores indicate better self-care. Standardized scoring will assess changes from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores on the Feasibility of Intervention Measure (FIM) at 90 Days | 90 days | This metric uses the FIM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. Higher scores suggest greater perceived feasibility of the CHAT intervention. |
| Scores on the Intervention Appropriateness Measure (IAM) at 90 Days | 90 days | This measure uses the IAM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The IAM assesses perceived appropriateness of the CHAT intervention. Higher scores suggest better perceived alignment with patient needs. |
| Scores on the Acceptability of Intervention Measure (AIM) at 90 Days | 90 days | This measure uses the AIM, a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The AIM evaluates participants' perceptions of the CHAT intervention's acceptability. Higher scores suggest better acceptance by participants. |
| Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days | Baseline, 90 days | This metric assesses engagement in Advance Care Planning (ACP) using a 4-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'I have never thought about it ' and the highest score of 5 indicates 'I have already done it'. The mean score is calculated, with higher scores indicating increased engagement in ACP. |
| Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days | Baseline, 90 days | This metric assesses readiness in Advance Care Planning (ACP) using an 8-item survey rated on a 7-point Likert scale, where the lowest score of 1 indicates 'strongly disagree' and the highest score of 7 indicates 'strongly agree'. The mean score is calculated, with higher scores indicating increased readiness in ACP. |
| Mean Change from Baseline for Percentage of Participants Completing a Health Care Proxy Form at 90 days | Baseline, 90 days | This measure uses the Advance Directive Completion Question to count the number of participants who complete a health care proxy form, out of the number of total study participants, reflecting their engagement in Advance Care Planning. |
| Mean Change from Baseline for Percentage of Participants Completing a Living Will Form at 90 days | Baseline, 90 days | This measure uses the Advance Directive Completion Question to count the number of participants who complete a living will form, out of the number of total study participants, reflecting their involvement in planning for future healthcare decisions. |
| Mean Change from Baseline on the Perceived Health Competency Scale (PHCS) at 90 Days | Baseline, 90 days | The PHCS is an 8-item survey, rated on a 5-point Likert scale, where the lowest score of 1 indicates 'strongly disagree' and the highest score of 5 indicates 'strongly agree'. Scores are calculated by summing item responses, with higher scores indicating greater perceived ability to manage health. |
| Mean Change from Baseline on the Patient Activation Measure (PAM) at 90 Days | Baseline, 90 days | The PAM is a 10-item survey, rated on a 4-point Likert scale, where the lowest score of 1 indicates 'disagree strongly' and the highest score of 4 indicates 'agree strongly'. Scores are calculated by summing item responses and converting them to an overall activation level, with higher scores indicating greater self-management and engagement in health. |
| Mean Change from Baseline on The Human Connection (THC) Scale at 90 Days | Baseline, 90 days | The Human Connection (THC) Scale measures therapeutic alliance with 16 items rated on a 4-point Likert scale, with the lowest possible score of 1 and the highest possible score of 4. The mean score reflects perceived improvements in the therapeutic relationship. |
| Mean Change from Baseline on the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) Relatedness Subscale at 90 Days | Baseline, 90 days | This measure uses the Relatedness Subscale of the BPNSF, an 8-item survey rated on a 5-point Likert scale, where the lowest score of 1 indicates 'completely disagree' and the highest score of 5 indicates 'completely agree'. The BPNSF assesses perceived satisfaction and frustration in relationships. Higher scores indicate greater satisfaction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORParag Goyal, MD, MSc
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORMegan J Shen, PhD
Fred Hutchinson Cancer Center
Outcome results
None listed