Trial Outcomes & Findings for Caregiver Self-Management Needs Through Skill-Building (NCT NCT03635151)

Last Updated: 2024-04-18

Results Overview

Caregiver satisfaction ratings (usability, ease of use, acceptability) for both TASK III and ISR programs are measured using the Caregiver Satisfaction Scale (CSS). The CSS consists of 9 items rated on a response scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. Items are summed for a total score, then divided by 9 (number of items) with a possible range of 1 to 5. Higher scores indicate greater satisfaction.

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	TASK III Group The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Overall Study STARTED	36	38
Overall Study COMPLETED	31	34
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Caregiver Self-Management Needs Through Skill-Building

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TASK III Group n=36 Participants The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group n=38 Participants The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.	Total n=74 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 13 • n=5 Participants	56 years STANDARD_DEVIATION 17 • n=7 Participants	57 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Patient Health Questionnaire Depression Scale (PHQ-9)	5.36 units on a scale STANDARD_DEVIATION 6.02 • n=5 Participants	4.95 units on a scale STANDARD_DEVIATION 3.88 • n=7 Participants	5.15 units on a scale STANDARD_DEVIATION 5.01 • n=5 Participants
Bakas Caregiving Outcomes Scale (BCOS)	51.72 units on a scale STANDARD_DEVIATION 9.71 • n=5 Participants	53.71 units on a scale STANDARD_DEVIATION 12.95 • n=7 Participants	52.74 units on a scale STANDARD_DEVIATION 11.45 • n=5 Participants
Unhealthy Days	9.03 Days STANDARD_DEVIATION 10.57 • n=5 Participants	9.97 Days STANDARD_DEVIATION 9.08 • n=7 Participants	9.51 Days STANDARD_DEVIATION 9.78 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	TASK III Group n=31 Participants The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group n=34 Participants The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS).	4.59 score on a scale Standard Deviation .47	4.15 score on a scale Standard Deviation .59

SECONDARY outcome

Timeframe: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.

Population: As in our prior studies, the number of minutes on the TASK III and ISR calls from the nurse were controlled in our analyses showing data trends as change scores. At each follow-up time point, 8 and 12 weeks, we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline to 8 weeks.

Caregiver depressive symptoms are measured by the Patient Health Questionnaire Depression Scale (PHQ-9) consisting of 9 items rated on a response scale ranging from 0 = Not at all to 3 = Nearly every day. Items are summed for a total score with a possible range of 0 to 27. Higher scores indicate higher depressive symptoms.

Outcome measures

Outcome measures
Measure	TASK III Group n=31 Participants The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group n=34 Participants The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).	-2.3 units on a scale Standard Error 0.7	-0.6 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.

Caregiver life changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) are measured by the Bakas Caregiving Outcomes Scale (BCOS). The BCOS consists of 15 items rated on a response scale ranging from -3 (changed for the worst) to +3 (Changed for the best). The items are recoded (-3 = 1) (-2 = 2) (-1 = 3) (0 = 4) (1 = 5) (2 = 6) (3 = 7) so that positive numbers can be obtained for analysis. The recoded responses to the 15 items are summed for a total score with a possible range of 15-105. Higher scores indicate more positive life changes as a result of providing care.

Outcome measures

Outcome measures
Measure	TASK III Group n=31 Participants The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group n=34 Participants The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Life Changes (i.e., Changes in Social Functioning, Subjective Well-being, and Physical Health as a Result of Providing Care) Measured by the Bakas Caregiving Outcomes Scale (BCOS).	11.2 units on a scale Standard Error 2.6	3.1 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.

Population: At each follow-up time point, 8 and 12 weeks, we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline to 8 weeks.

Caregiver unhealthy days are measured using the Unhealthy Days (UD) measure consisting of two items: How many days during the past 30 days was your physical health not good?; How many days during the past 30 days was your mental health not good? These items range from 0 = no unhealthy days to 30 = 30 unhealthy days. The two items are summed for a total score, with a cap of 30 days. Higher scores indicate more unhealthy days in the past 30 days.

Outcome measures

Outcome measures
Measure	TASK III Group n=31 Participants The Telephone Assessment and Skill-Building Kit (TASK III) group Telephone Assessment and Skill-Building Kit (TASK III) Group: The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.	ISR Group n=34 Participants The Information, Support, and Referral (ISR) group Information Support and Referral (ISR) Group: The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Unhealthy Days Measured by the Number of Unhealthy Days in the Past 30 Days.	1.93 Days Standard Error 1.70	-1.15 Days Standard Error 1.72

Adverse Events

TASK III Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ISR 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

Tamilyn Bakas

University of Cincinnati College of Nursing

Phone: 513-558-2254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place