Trial Outcomes & Findings for Caregiver Support in the Context of Multiple Chronic Conditions (NCT NCT04090749)
NCT ID: NCT04090749
Last Updated: 2023-12-22
Results Overview
The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
16 weeks and 32 weeks
Results posted on
2023-12-22
Participant Flow
Of the 38 enrolled participants, 3 withdrew and 8 were lost to follow up prior to baseline data collection and randomization.
Participant milestones
| Measure |
Open Label Pilot
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
The immediate intervention group (n=20) will receive the intervention during weeks 0-16. There will be assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
The waitlist control group (n=20) will be provided written materials with community resources for caregivers during the first 16 weeks, then the intervention will begin.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
|---|---|---|---|
|
Open Label Pilot
STARTED
|
3
|
0
|
0
|
|
Open Label Pilot
COMPLETED
|
2
|
0
|
0
|
|
Open Label Pilot
NOT COMPLETED
|
1
|
0
|
0
|
|
Pilot Trial
STARTED
|
0
|
12
|
12
|
|
Pilot Trial
COMPLETED
|
0
|
10
|
11
|
|
Pilot Trial
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Open Label Pilot
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
The immediate intervention group (n=20) will receive the intervention during weeks 0-16. There will be assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
The waitlist control group (n=20) will be provided written materials with community resources for caregivers during the first 16 weeks, then the intervention will begin.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
|---|---|---|---|
|
Open Label Pilot
Lost to Follow-up
|
1
|
0
|
0
|
|
Pilot Trial
Care recipient of enrolled caregiver died
|
0
|
1
|
0
|
|
Pilot Trial
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Caregiver Support in the Context of Multiple Chronic Conditions
Baseline characteristics by cohort
| Measure |
Open Label Pilot
n=3 Participants
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
n=12 Participants
The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
n=12 Participants
The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 19.6 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
59 years
STANDARD_DEVIATION 16.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Caregiver Burden
|
14.8 units on a scale
STANDARD_DEVIATION 10 • n=5 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 11.2 • n=7 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
14.75 units on a scale
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Quality of Life (mental)
|
65.2 units on a scale
STANDARD_DEVIATION 17.1 • n=5 Participants
|
63.4 units on a scale
STANDARD_DEVIATION 18.8 • n=7 Participants
|
77.6 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
70.5 units on a scale
STANDARD_DEVIATION 19.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeks and 32 weeksPopulation: 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection.
The Short Form Health Survey (36 items) measures self-rated quality of life using 8 sub-scales. Items are scored on a 0-100 range, with total scores averaged for each subscale. The eight domains are also averaged to create an overall score from 0-100. Higher scores indicate a more favorable health state.
Outcome measures
| Measure |
Open Label Pilot
n=2 Participants
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
n=10 Participants
The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
n=11 Participants
The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began.
|
|---|---|---|---|
|
Quality of Life as Assessed by the Short Form Health Survey
16 weeks
|
72.3 units on a scale
Standard Deviation 25.9
|
74.1 units on a scale
Standard Deviation 20.6
|
70.4 units on a scale
Standard Deviation 20.6
|
|
Quality of Life as Assessed by the Short Form Health Survey
32 weeks
|
—
|
76.1 units on a scale
Standard Deviation 21.2
|
74.0 units on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: 16 weeks and 32 weeksPopulation: 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection.
The PROMIS 7-item fatigue measure has a score range from 0-35 with higher scores indicating higher levels of fatigue. We use T-scores for analysis (where standard scores with a mean of 50 and standard deviation of 10 in the U.S. general population).
Outcome measures
| Measure |
Open Label Pilot
n=2 Participants
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
n=10 Participants
The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
n=11 Participants
The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began.
|
|---|---|---|---|
|
Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
16 weeks
|
50.3 units on a scale
Standard Deviation 8.1
|
54.3 units on a scale
Standard Deviation 7.7
|
49.1 units on a scale
Standard Deviation 10.7
|
|
Fatigue as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
32 weeks
|
—
|
48.2 units on a scale
Standard Deviation 9
|
53.6 units on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 16 weeks and 32 weeksPopulation: 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection.
The investigators will use the task difficulty and time caring subscales of the Oberst Caregiving Burden Scale, which include 15 likert scale items. Scores range from 15-75. Higher scores indicate greater task difficulty and more time spent on each task, higher burden.
Outcome measures
| Measure |
Open Label Pilot
n=2 Participants
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
n=10 Participants
The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
n=11 Participants
The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began.
|
|---|---|---|---|
|
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale
16 weeks
|
44 units on a scale
Standard Deviation 4.8
|
46 units on a scale
Standard Deviation 3.4
|
39.3 units on a scale
Standard Deviation 4.5
|
|
Caregiver Burden as Assessed by the Oberst Caregiving Burden Scale
32 weeks
|
—
|
38.5 units on a scale
Standard Deviation 3.2
|
37.5 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 16 weeks and 32 weeksPopulation: 1 open label pilot participant did not start the intervention after completing the baseline surveys and did not complete subsequent timepoints for the surveys. The open label pilot participants did not complete the 32 week data collection.
The ZBI is a 12 item measure with higher scores representing higher feelings of burden; the range of summed scores is 0-48.
Outcome measures
| Measure |
Open Label Pilot
n=2 Participants
This group was the first consented participants and was not randomized, but instead all participants received the intervention. Information from this group was used to test study procedures and make final minor changes to the intervention protocol.
|
Immediate Intervention
n=10 Participants
The immediate intervention group received the intervention during weeks 0-16. There was an assessment at week 32 to examine maintenance on primary and secondary outcomes.
Caregiver-Support: intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
|
Waitlist Control
n=11 Participants
The waitlist control group was provided written materials with community resources for caregivers during the first 16 weeks, then the intervention began.
|
|---|---|---|---|
|
Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)
16 weeks
|
13.9 units on a scale
Standard Deviation 10.2
|
11.3 units on a scale
Standard Deviation 10.6
|
14.8 units on a scale
Standard Deviation 10.6
|
|
Caregiver Burden as Assessed by the Zarit Caregiver Burden Interview (ZBI)
32 weeks
|
—
|
10.2 units on a scale
Standard Deviation 9
|
9.9 units on a scale
Standard Deviation 9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 16 weeks and 32 weeksParticipants will wear a non-occlusive sweatpatch to collect interleukin 6. Higher levels of interleukin 6 suggest increased activation of inflammatory response and decreased resilience to stress.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 16 weeks and 32 weeksParticipants will wear a non-occlusive sweatpatch to collect interleukin 10. Higher levels of interleukin 10 suggest increased activation of the anti-inflammatory response and increased resilience to stress.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 16 weeks and 32 weeksParticipants will touch a finger pad for 2-5 minutes to obtain heart rate variability. Heart rate variability is assessed through multiple calculations including: percentage of pairs of adjacent N-N intervals differing by more than 50 milliseconds (pNN50), high-frequency power (HF power), and low frequency to high frequency (LF/HF) ratio. Higher pNN50, HF power and LF/HF ratio levels suggest increased resilience to stress.
Outcome measures
Outcome data not reported
Adverse Events
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Label Pilot
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