Trial Outcomes & Findings for Heart Failure Resilience Intervention for Caregivers (NCT NCT03963583)

Last Updated: 2025-11-24

Results Overview

Investigators will use the task difficulty and time caregiving subscales of the Oberst Caregiving Burden Scale. Both sub-scales include 15 likert scale items each. Scores range from 15-75 for the task difficulty and 15-75 for the time caregiving sub-scales. Higher scores indicate great task difficulty; higher scores indicate more time spent caregiving. Sub-scales are not combined in a total score.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Baseline, 12 and 24 weeks

Results posted on

2025-11-24

Participant Flow

Of the 33 enrolled caregivers (participants): Withdrawn (n=10) , Lost to Follow-Up (n=2) , Determined not eligible (n=2), nineteen caregivers were randomized to the arms.

Participant milestones

Participant milestones
Measure	HEROIC Intervention Group This group will receive the HEROIC intervention.	Waitlist Control Group The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.
Overall Study STARTED	10	9
Overall Study 12-weeks	8	9
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Failure Resilience Intervention for Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HEROIC Intervention Group n=10 Participants This group will receive the HEROIC intervention.	Waitlist Control Group n=9 Participants The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.	Total n=19 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Black or African American	5 Participants n=45 Participants	3 Participants n=12929 Participants	8 Participants n=6349 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 10.7 • n=45 Participants	55.9 years STANDARD_DEVIATION 15.8 • n=12929 Participants	57.6 years STANDARD_DEVIATION 13.1 • n=6349 Participants
Sex: Female, Male Female	9 Participants n=45 Participants	9 Participants n=12929 Participants	18 Participants n=6349 Participants
Sex: Female, Male Male	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) White	5 Participants n=45 Participants	6 Participants n=12929 Participants	11 Participants n=6349 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants

PRIMARY outcome

Timeframe: Baseline, 12 and 24 weeks

Population: Participants with complete case data at each time point

The Goal Attainment Scale is a self-reported attainment of goals implementing health-promoting behaviors, reported on a 5-point scale. Scores are converted to t-scores (0-100). 50 indicates the population mean with a standard deviation of 10. Higher scores indicate higher goal attainment.

Outcome measures

Outcome measures
Measure	HEROIC Intervention Group n=8 Participants This group will receive the HEROIC intervention.	Waitlist Control Group n=6 Participants The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.
Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale 24-weeks	68 t-score Standard Deviation 4.5	51.7 t-score Standard Deviation 9.9
Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale Baseline	40 t-score Standard Deviation 0	40 t-score Standard Deviation 0
Goal Attainment of Preventive Health Behaviors as Measured by the Goal Attainment Scale 12 weeks	57.5 t-score Standard Deviation 8.9	52.5 t-score Standard Deviation 13.9

PRIMARY outcome

Timeframe: Baseline, 12 and 24 weeks

Population: Participants with complete case data at each time point

Outcome measures

Outcome measures
Measure	HEROIC Intervention Group n=8 Participants This group will receive the HEROIC intervention.	Waitlist Control Group n=6 Participants The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale 12-weeks - Time	49.5 score on a scale Standard Deviation 13.5	51.6 score on a scale Standard Deviation 11.5
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale 24-weeks - Difficulty	34.4 score on a scale Standard Deviation 21.1	45.4 score on a scale Standard Deviation 27.9
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale Baseline - Time	52.4 score on a scale Standard Deviation 13.1	49.3 score on a scale Standard Deviation 13.5
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale 24-weeks - Time	42.8 score on a scale Standard Deviation 21.3	57.4 score on a scale Standard Deviation 15.2
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale Baseline - Difficulty	50.2 score on a scale Standard Deviation 16.7	46.8 score on a scale Standard Deviation 17.8
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale 12-weeks - Difficulty	40.9 score on a scale Standard Deviation 18.3	43.0 score on a scale Standard Deviation 24.2

PRIMARY outcome

Timeframe: Baseline, 12 and 24 weeks

Population: Participants with complete case data at each time point

9-Item Neurological Quality of Life (Neuro-QOL). Items are scored on a 1-5 range, with total summary score calculated range of 9-45. Higher scores indicate a more favorable quality of life.

Outcome measures

Outcome measures
Measure	HEROIC Intervention Group n=8 Participants This group will receive the HEROIC intervention.	Waitlist Control Group n=6 Participants The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.
Quality of Life as Assessed by the Neurological Quality of Life(Neuro-QOL) Baseline	36.2 score on a scale Standard Deviation 6.2	34.4 score on a scale Standard Deviation 6.9
Quality of Life as Assessed by the Neurological Quality of Life(Neuro-QOL) 12-weeks	37.3 score on a scale Standard Deviation 4.3	31.4 score on a scale Standard Deviation 8.0
Quality of Life as Assessed by the Neurological Quality of Life(Neuro-QOL) 24-weeks	38.0 score on a scale Standard Deviation 5.5	33.5 score on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline, 12 and 24 weeks

Population: Participants with complete case data at each time point.

The coping self-efficacy scale has 13 items, each scored 0-10. Scores range from 0-130. Higher scores indicate higher coping self-efficacy.

Outcome measures

Outcome measures
Measure	HEROIC Intervention Group n=8 Participants This group will receive the HEROIC intervention.	Waitlist Control Group n=6 Participants The waitlisted group will receive usual care for caregivers for the first 12 weeks, which is normally limited to inclusion in some clinical assessment and teaching during patient visits. Waitlisted participants will receive monthly study postcards to encourage retention. After 12 weeks, they will begin the intervention.
Self-Efficacy as Assessed by the Coping Self Efficacy Scale Baseline	92.1 score on a scale Standard Deviation 22.3	85.6 score on a scale Standard Deviation 26.1
Self-Efficacy as Assessed by the Coping Self Efficacy Scale 12-weeks	79.3 score on a scale Standard Deviation 34.1	71.0 score on a scale Standard Deviation 25.0
Self-Efficacy as Assessed by the Coping Self Efficacy Scale 24-weeks	98.5 score on a scale Standard Deviation 21.2	84.6 score on a scale Standard Deviation 30.8

Adverse Events

HEROIC Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martha Abshire Saylor

Johns Hopkins University School of Nursing

Phone: 4433406201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place