Trial Outcomes & Findings for Self-Management in Parents of Technology-Dependent Children (NCT NCT04105244)
NCT ID: NCT04105244
Last Updated: 2024-06-06
Results Overview
Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baseline
Results posted on
2024-06-06
Participant Flow
There were 5 participants who signed the consent form but did not complete the baseline surveys and therefore they were not randomized and therefore not analyzed.
Participant milestones
| Measure |
Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
100
|
|
Overall Study
COMPLETED
|
67
|
62
|
|
Overall Study
NOT COMPLETED
|
30
|
38
|
Reasons for withdrawal
| Measure |
Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
|
Overall Study
Lost to Follow-up
|
20
|
15
|
|
Overall Study
Parent no longer eligible- child not living at home
|
0
|
2
|
|
Overall Study
Unable to contact to complete the intervention.
|
0
|
9
|
Baseline Characteristics
Self-Management in Parents of Technology-Dependent Children
Baseline characteristics by cohort
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: The intervention includes self-help and help-seeking skills.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 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)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
100 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Duration of Caregiving for Technology-Dependent Child
|
43.3 months
STANDARD_DEVIATION 52.2 • n=5 Participants
|
49.5 months
STANDARD_DEVIATION 47.4 • n=7 Participants
|
46.3 months
STANDARD_DEVIATION 49.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
Mental Health Related Quality of Life (The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Mental Health (GMH) score converted to a T-Score metric - produces a physical and a mental health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept being measured or better mental health.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Psychological Outcome- Health Related Quality of Life
Baseline- Time 1
|
40.5 score on a scale
Standard Deviation 9.21
|
37.0 score on a scale
Standard Deviation 8.85
|
|
Psychological Outcome- Health Related Quality of Life
6 weeks- Time 2
|
41.9 score on a scale
Standard Deviation 8.95
|
39.70 score on a scale
Standard Deviation 9.31
|
|
Psychological Outcome- Health Related Quality of Life
3 months- Time 3
|
41.7 score on a scale
Standard Deviation 8.23
|
40.70 score on a scale
Standard Deviation 9.04
|
|
Psychological Outcome- Health Related Quality of Life
6 months- Time 4
|
42.60 score on a scale
Standard Deviation 9.41
|
41.00 score on a scale
Standard Deviation 10.00
|
|
Psychological Outcome- Health Related Quality of Life
9 months- Time 5
|
42.40 score on a scale
Standard Deviation 8.87
|
42.50 score on a scale
Standard Deviation 8.61
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
Screening Measure for Early Detection of Depressive Symptoms: The Depressive Cognition Scale. Measures depressive cognitions and negative thoughts that may lead to clinical depression. Eight (8) Items. Score Range: 0 - 40. Higher scores indicating more depressive cognitions.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Depressive Cognitions
Baseline- Time 1
|
6.31 score on a scale
Standard Deviation 5.09
|
8.27 score on a scale
Standard Deviation 6.63
|
|
Depressive Cognitions
6 weeks- Time 2
|
6.93 score on a scale
Standard Deviation 5.73
|
8.62 score on a scale
Standard Deviation 6.27
|
|
Depressive Cognitions
3 months- Time 3
|
6.13 score on a scale
Standard Deviation 2.08
|
8.17 score on a scale
Standard Deviation 6.56
|
|
Depressive Cognitions
6 months- Time 4
|
5.84 score on a scale
Standard Deviation 5.78
|
8.20 score on a scale
Standard Deviation 7.32
|
|
Depressive Cognitions
9 months- Time 5
|
6.24 score on a scale
Standard Deviation 6.06
|
6.69 score on a scale
Standard Deviation 6.10
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
(The Patient-Reported Outcomes Measurement Information System \[PROMIS\] Short Form version 1.2- Global Health). Ten (10) Items. Score Range: 10 - 50. Global Physical Health (GPH) score converted to a T-Score metric - produces a physical health score. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Higher T-score means better physical health.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Physical Outcome
Baseline- Time 1
|
44.90 score on a scale
Standard Deviation 7.58
|
44.00 score on a scale
Standard Deviation 7.28
|
|
Physical Outcome
6 weeks- Time 2
|
46.00 score on a scale
Standard Deviation 7.22
|
45.00 score on a scale
Standard Deviation 8.07
|
|
Physical Outcome
3 months- Time 3
|
45.00 score on a scale
Standard Deviation 7.31
|
46.10 score on a scale
Standard Deviation 8.01
|
|
Physical Outcome
6 months- Time 4
|
45.10 score on a scale
Standard Deviation 8.07
|
46.40 score on a scale
Standard Deviation 8.53
|
|
Physical Outcome
9 months- Time 5
|
46.00 score on a scale
Standard Deviation 7.23
|
48.20 score on a scale
Standard Deviation 8.19
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
Appraised Sleep Quality (Pittsburgh Sleep Quality Index), Pittsburgh Sleep Quality Index The Pittsburgh Sleep Quality Index (PSQI). Assesses sleep quality and disturbances over a l-month time interval. Nineteen (19) items are grouped into seven component scores, each weighted equally on a 0-3 scale. Score Range (Global PSQI Score) is 0-21. Higher scores indicate worse sleep quality. Sub Scales are summed
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Self-Management- Sleep- Subjective
3 months- Time 3
|
6.278 score on a scale
Standard Deviation 3.4
|
6.768 score on a scale
Standard Deviation 2.68
|
|
Self-Management- Sleep- Subjective
Baseline- Time 1
|
7.134 score on a scale
Standard Deviation 3.239
|
7.59 score on a scale
Standard Deviation 2.903
|
|
Self-Management- Sleep- Subjective
6 months- Time 4
|
6.058 score on a scale
Standard Deviation 3.014
|
6.406 score on a scale
Standard Deviation 2.866
|
|
Self-Management- Sleep- Subjective
9 months- Time 5
|
6.254 score on a scale
Standard Deviation 2.93
|
6.161 score on a scale
Standard Deviation 2.729
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
Personal Lifestyle Questionnaire- Positive Health Practices Personal Lifestyle Questionnaire (PLQ). Measures the positive health practices of exercise, substance use, nutrition, relaxation, safety, and health promotion. Twenty-four (24) items 4-point summated rating scale with a range of possible scores from 24 to 96 Higher scores reflect the practice of more health behaviors. Total scores are reported.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Positive Health Practices
Female Baseline- Time 1
|
64.515 score on a scale
Standard Deviation 8.963
|
64.4 score on a scale
Standard Deviation 8.357
|
|
Positive Health Practices
Female 6 weeks- Time 2
|
65.767 score on a scale
Standard Deviation 9.054
|
65.811 score on a scale
Standard Deviation 9.727
|
|
Positive Health Practices
Female 3 months- Time 3
|
66.805 score on a scale
Standard Deviation 9.159
|
67.352 score on a scale
Standard Deviation 8.626
|
|
Positive Health Practices
Female 6 months- Time 4
|
67.743 score on a scale
Standard Deviation 8.421
|
68.277 score on a scale
Standard Deviation 8.592
|
|
Positive Health Practices
Female 9 months- Time 5
|
66.642 score on a scale
Standard Deviation 8.433
|
69.0 score on a scale
Standard Deviation 9.987
|
|
Positive Health Practices
Male Baseline- Time 1
|
63.227 score on a scale
Standard Deviation 8.433
|
63.35 score on a scale
Standard Deviation 8.158
|
|
Positive Health Practices
Male 6 weeks- Time 2
|
64.233 score on a scale
Standard Deviation 8.714
|
64.757 score on a scale
Standard Deviation 9.379
|
|
Positive Health Practices
Male 3 months- Time 3
|
65.439 score on a scale
Standard Deviation 8.844
|
66.254 score on a scale
Standard Deviation 8.397
|
|
Positive Health Practices
Male 6 months- Time 4
|
66.329 score on a scale
Standard Deviation 8.156
|
67.2 score on a scale
Standard Deviation 8.337
|
|
Positive Health Practices
Male 9 months- Time 5
|
65.269 score on a scale
Standard Deviation 8.288
|
67.597 score on a scale
Standard Deviation 9.565
|
PRIMARY outcome
Timeframe: Change Measured over 9 months of the study (baseline and 6 weeks, 3 months, 6 months, 9 months after baselinePopulation: The number in the rows differs from the overall number analyzed because some of the participants withdrew or were lost to follow up.
"Patient Reported Outcomes Measurement Information System (PROMIS)Short Form - Depressive Symptoms "Patient Reported Outcomes Measurement Information System (PROMIS)Short Form Version 1.0 - Depression 8a. Assess self-reported negative mood , views of self , social cognition, and decreased positive affect and engagement." Eight (8) Items. Score Range: 5 (Min)-40 (Max). Total Score is reported. The score is converted to a T-Score metric. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. A higher PROMIS T-score represents more of the concept (depression) being measured thus a T-score of 60 is one standard deviation worse related to the concept of depression than average.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Depressive Symptoms
Baseline- Time 1
|
51.80 score on a scale
Standard Deviation 7.56
|
55.10 score on a scale
Standard Deviation 7.87
|
|
Depressive Symptoms
6 weeks- Time 2
|
51.00 score on a scale
Standard Deviation 7.53
|
53.10 score on a scale
Standard Deviation 8.36
|
|
Depressive Symptoms
3 months- Time 3
|
50.10 score on a scale
Standard Deviation 8.30
|
52.20 score on a scale
Standard Deviation 8.11
|
|
Depressive Symptoms
6 months- Time 4
|
50.20 score on a scale
Standard Deviation 8.45
|
50.90 score on a scale
Standard Deviation 9.05
|
|
Depressive Symptoms
9 months- Time 5
|
49.90 score on a scale
Standard Deviation 8.74
|
50.80 score on a scale
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: Up to 9 monthsNumber of Technology-Dependent Children with ER Visits over the time period the parent was enrolled and participating in the study from review of the children's charts.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Number of Technology-Dependent Children With ER Visits
|
0.9592 Number of ER visits
Standard Deviation 1.566
|
0.9108 Number of ER visits
Standard Deviation 1.569
|
SECONDARY outcome
Timeframe: Up to 9 monthsNumber of Technology-Dependent Children with Rehospitalizations over the time period the parent was enrolled and participating in the study from review of the children's charts.
Outcome measures
| Measure |
Attention Control
n=97 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post-enrollment plus the current standard of care, whereby caregivers phone their healthcare providers when they have questions or concerns.
|
Resourcefulness Training Intervention©
n=100 Participants
The Resourcefulness Training© arm will receive (a) individually tailored instruction on personal and social resourcefulness skills via the Resourcefulness Video and intervention nurse, (b) journal-writing instruction to describe resourcefulness application, (c) access to the study website with videotape vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life and Resourcefulness Video, and (d) boosters at 2 and 4 months post-enrollment that will include reinforcement of skills learned and additional journal writing.
Resourcefulness Training©: Cognitive-behavioral intervention includes personal (self-help) and social (help-seeking) resourcefulness skills.
|
|---|---|---|
|
Number of Technology-Dependent Children With Rehospitalizations
|
0.7755 Number of rehospitalizations
Standard Deviation 1.343
|
0.8415 Number of rehospitalizations
Standard Deviation 1.384
|
Adverse Events
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resourcefulness Training Intervention©
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
Valerie Boebel Toly, PhD, RN, CPNP-PC, FAAN
Frances Payne Bolton School of Nursing, Case Western Reserve University
Phone: 216-534-5844
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place