Trial Outcomes & Findings for Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP (NCT NCT05292365)
NCT ID: NCT05292365
Last Updated: 2024-12-19
Results Overview
Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves. This Outcome Measure was assessed by child.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
up to 3 months
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
RE-PACT Intervention: Child
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
RE-PACT Intervention: Caregiver
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
Active Control (AC): Child
AC subjects will receive usual comprehensive medical care and coordination.
|
Active Control (AC): Caregiver
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
24
|
24
|
|
Overall Study
COMPLETED
|
35
|
34
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
RE-PACT Intervention: Child
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
RE-PACT Intervention: Caregiver
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
Active Control (AC): Child
AC subjects will receive usual comprehensive medical care and coordination.
|
Active Control (AC): Caregiver
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|---|---|
|
Overall Study
Met Exclusion Criteria: Participant disenrolled from their complex care program
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
Baseline characteristics by cohort
| Measure |
RE-PACT Intervention: Child
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
RE-PACT Intervention: Caregiver
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
Active Control (AC): Child
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
Active Control (AC): Caregiver
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
36 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
24 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
60 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=36 Participants
|
35 Participants
n=35 Participants
|
0 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
59 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Age, Continuous
Child
|
11 years
n=36 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
—
|
9 years
n=24 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
—
|
10 years
n=60 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
|
Age, Continuous
Caregiver
|
—
|
42 years
n=35 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
—
|
37 years
n=24 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
40 years
n=59 Participants • Per the planned analyses, totals were calculated separately for participants in the caregiver and child groups
|
|
Sex: Female, Male
Female
|
10 Participants
n=36 Participants • Missing data due to non-response
|
32 Participants
n=35 Participants • Missing data due to non-response
|
11 Participants
n=22 Participants • Missing data due to non-response
|
22 Participants
n=22 Participants • Missing data due to non-response
|
75 Participants
n=115 Participants • Missing data due to non-response
|
|
Sex: Female, Male
Male
|
26 Participants
n=36 Participants • Missing data due to non-response
|
3 Participants
n=35 Participants • Missing data due to non-response
|
11 Participants
n=22 Participants • Missing data due to non-response
|
0 Participants
n=22 Participants • Missing data due to non-response
|
40 Participants
n=115 Participants • Missing data due to non-response
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=36 Participants
|
12 Participants
n=35 Participants
|
9 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
39 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=36 Participants
|
21 Participants
n=35 Participants
|
12 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
70 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=119 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=119 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=36 Participants
|
25 Participants
n=35 Participants
|
12 Participants
n=24 Participants
|
15 Participants
n=24 Participants
|
78 Participants
n=119 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=36 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
8 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
19 Participants
n=119 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
35 participants
n=35 Participants
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
119 participants
n=119 Participants
|
PRIMARY outcome
Timeframe: up to 3 monthsPopulation: \*Recruitment duration was not stratified by arm.
Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=60 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Number of Days to Meet Target Enrollment Size
Wave 1
|
56 Days
|
—
|
|
Feasibility: Number of Days to Meet Target Enrollment Size
Wave 2
|
29 Days
|
—
|
|
Feasibility: Number of Days to Meet Target Enrollment Size
Wave 3
|
129 Days
|
—
|
PRIMARY outcome
Timeframe: up to 3 monthsFeasibility will, in part, be measured by the number of days between randomization and (time zero) intervention activities. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Median Number of Days Between Randomization and Intervention Activities
|
4 Days
Interval 3.5 to 7.0
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFeasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Mean Number of Minutes Logged for Action Planning
|
22.8 Minutes
Standard Deviation 10.9
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFeasibility will, in part, be measured by the amount of time it takes to deliver the intervention. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching
|
86.8 Minutes
Standard Deviation 122.2
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFeasibility will, in part, be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory triggers. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Mean Number of Intervention Triggers Per Patient
|
0.7 Intervention Triggers
Standard Deviation 1
|
—
|
PRIMARY outcome
Timeframe: up to 22 monthsPopulation: Number analyzed represents the number of participants by wave.
Feasibility will in part be measured by the presence of necessary data infrastructure issues. This is a measure of the presence of complete data collection, between 2 sites, data use agreements and Institutional Review Board reliance. This outcome includes any events that occur over the study duration.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=60 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Feasibility: Incidence of Data Infrastructure Issues
Wave 1
|
0 Data Infrastructure Issues
|
—
|
|
Feasibility: Incidence of Data Infrastructure Issues
Wave 2
|
0 Data Infrastructure Issues
|
—
|
|
Feasibility: Incidence of Data Infrastructure Issues
Wave 3
|
0 Data Infrastructure Issues
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: The number of participants analyzed must reflect the number of participants approached in addition to those consented. Enrollment rate was not stratified by arm.
Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached + potentially eligible. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=149 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Participant Enrollment Rate
|
60 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form. This Outcome Measure was assessed in caregivers.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=133 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Does not have Cerebral Palsy
|
9 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Does not meet motor function criteria
|
10 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Does not receive respiratory care
|
16 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Not enrolled in a complex care program
|
6 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Moving out of the area
|
1 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Ineligible: Does not meet English or Spanish language proficiency
|
2 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Recruitment completed before enrollment
|
4 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Not interested in the intervention
|
35 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Not interested in research
|
5 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Too busy
|
7 Participants
|
—
|
|
Acceptability: Categorized Reasons for Consent Refusal
Unable to contact
|
38 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Participant Drop Out Rate
Completed Intervention
|
35 Participants
|
24 Participants
|
|
Acceptability: Participant Drop Out Rate
Dropped-out
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability of the intervention will in part be measured by the participant feedback. \- The number of months, on average, where participants reported use of an action plan. This Outcome Measure was assessed by dyad.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan
|
1.6 Months
Standard Deviation 1.6
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability of the intervention will in part be measured by the participant feedback. \- Number of participants reporting definite or probably recommendation of action planning to others. This Outcome Measure was assessed by dyad.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others
Probably or Definitely recommends action planning to others
|
25 Participants
|
—
|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others
Possibly, Probably not, or Definitely does not recommend action planning to others
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability of the intervention will in part be measured by the participant feedback. \- Number of participants reporting definite or probably recommendation of texting and clinical response to others. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others
Probably or Definitely recommends testing and/or clinical response to others
|
27 Participants
|
—
|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others
Possibly, Probably not, or Definitely does not recommend testing and/or clinical response to others
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability of the intervention will in part be measured by the participant feedback. \- 'How much would you want these approaches to continue as a part of regular care after the study is done?'. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done
Probably or Definitely wants these approaches to continue as a part of regular care
|
23 Participants
|
—
|
|
Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done
Possibly, Probably not, or Definitely does not want approaches to continue as a part of regular care
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsAcceptability of the intervention will in part be measured by composite score. The System Usability Scale is a 10-item survey scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher usability. Score range = 0 - 100. This Outcome Measure was assessed in dyads. To calculate the score: Step 1: Convert the scale into number for each of the 10 questions Strongly Disagree: 1 point Disagree: 2 points Neutral: 3 points Agree: 4 points Strongly Agree: 5 points Step 2: Calculate X = Sum of the points for all odd-numbered questions - 5 Y = 25 - Sum of the points for all even-numbered questions SUS Score = (X + Y) x 2.5
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Acceptability: System Usability Scale - Composite Score
|
79.5 score on a scale
Standard Deviation 11.7
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by the amount of time (in months) the participant was enrolled in the study. The target participation time is 6 months. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Time of Participant Enrollment in the Study
|
5.9 Months
Standard Deviation 0.5
|
6 Months
Standard Deviation 0
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Number of Respiratory Action Plans Per Patient
|
1 Respiratory Action Plans
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Number of Overall Action Plans Per Patient
|
1 Overall Action Plans
Standard Deviation 0
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: Rows are stratified by trigger type. There are 26 triggers total, of which n = 9 are due to caregiver confidence, n = 9 are due to hospital discharge, n = 4 are due to caregiver contact, and n = 4 are due to multiple triggers.
Fidelity of the intervention will in part be measured by the coaching visit success rate, which is the number of visits (at home or virtually) completed divided by the number of visits expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Intervention triggers
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Caregiver reported confidence < 5 · Clinical response completed for trigger
|
9 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Caregiver reported confidence < 5 · Clinical response NOT completed for trigger
|
0 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Hospital Discharge · Clinical response completed for trigger
|
9 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Hospital Discharge · Clinical response NOT completed for trigger
|
0 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Caregiver calls or messages complex care team · Clinical response completed for trigger
|
4 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Caregiver calls or messages complex care team · Clinical response NOT completed for trigger
|
0 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Multiple triggers · Clinical response completed for trigger
|
4 Intervention triggers
|
—
|
|
Fidelity: Coaching Visit Success Rate by Intervention Trigger
Trigger: Multiple triggers · Clinical response NOT completed for trigger
|
0 Intervention triggers
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: More follow-ups were completed than expected.
Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=5 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5
Number completed
|
20 Follow-Ups
|
—
|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5
Number expected
|
18 Follow-Ups
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: More follow-ups were completed than expected.
Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=5 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge
Number completed
|
30 Follow-Ups
|
—
|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge
Number expected
|
18 Follow-Ups
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: More follow-ups were completed than expected.
Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=4 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team
Number completed
|
9 Follow-Ups
|
—
|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team
Number expected
|
8 Follow-Ups
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: More follow-ups were completed than expected.
Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=3 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers
Number completed
|
10 Follow-Ups
|
—
|
|
Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers
Number expected
|
8 Follow-Ups
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by the response rate to mHealth text messages, which is the number of texts responded divided by the number of texts expected. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Text Message Response Rate
Number completed
|
867 Text messages
|
—
|
|
Fidelity: Text Message Response Rate
Number expected
|
889 Text messages
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component. This Outcome Measure was assessed in children.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Number of Participants Inappropriately Receiving Intervention
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 monthsPopulation: \*Data collection was not stratified by arm.
Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=60 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Data Collection Rate: Enrollment Surveys
|
59 Completed Enrollment Surveys
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsFidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=216 Monthly surveys
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Data Collection Rate: Monthly Surveys
|
210 Completed Monthly Surveys
|
—
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: \*Data collection was not stratified by arm.
Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible. This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=59 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Fidelity: Data Collection Rate: Exit Surveys
|
55 Completed Exit Surveys
|
—
|
SECONDARY outcome
Timeframe: up to 6 monthsSevere respiratory illness, defined as respiratory diagnoses requiring hospitalization. Respiratory diagnoses includes discharge diagnosis of any of the following: asthma, pneumonia (community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tracheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure. \- Number of children with at least 1 severe respiratory illness
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Incidence of Respiratory Diagnosis Requiring Hospitalization
Children with at least one severe respiratory illness
|
8 Participants
|
11 Participants
|
|
Incidence of Respiratory Diagnosis Requiring Hospitalization
Children with no severe respiratory illness
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsHospital days were summed by arm.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Total Hospital Days During Severe Respiratory Illness by Arm
|
8 Hospital Days
|
32 Hospital Days
|
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Number of Systemic Steroid Courses
Children with at least one systemic steroid course
|
3 Participants
|
3 Participants
|
|
Number of Systemic Steroid Courses
Children with no systemic steroid course
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Number of Systemic Antibiotic Courses
Children with at least one systemic antibiotic course throughout the study time frame
|
5 Participants
|
6 Participants
|
|
Number of Systemic Antibiotic Courses
Children with no systemic antibiotic course throughout the study time frame
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Number of Respiratory Emergency Department Visits
|
0 Respiratory ED Visits
|
3 Respiratory ED Visits
|
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=26 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Child Mortality Rate
Child death
|
0 Participants
|
0 Participants
|
|
Child Mortality Rate
No child death
|
26 Participants
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsCapability is in part measured by the FCAT mean composite score,. FCAT is a 10-item survey to assess the caregiver's challenges on the day it is taken, scored on a 5 point likert scale from 1 (disagree strongly) to 5 (agree strongly). The mean composite score ranges from 1 - 5 with higher scores indicating higher activation. Activation of a family member refers to their desire, knowledge, confidence, and skills that can inform engagement in healthcare.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=34 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=21 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score
|
4.5 score on a scale
Standard Deviation 0.4
|
4.5 score on a scale
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsCapability is in part measured by the GSES sum composite score. GSES is a 10-item survey scored on a 4-point Likert scale from 1 (not true at all) to 4 (exactly true). The sum composite score ranges from 10 - 40, with higher scores indicating higher efficacy.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=33 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=20 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score
|
34.2 score on a scale
Standard Deviation 4.4
|
35.3 score on a scale
Standard Deviation 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsOpportunity is assessed via the FECC score, using measure specifications for each item(s). The Care Coordination Question set assesses the statement "Care Coordinator Was Knowledgeable, Supportive and Advocated for Child's Needs" on a scale from 0 - 100 with * 0 = "Care Coordinator Was NOT Knowledgeable, Supportive and Advocated for Child's Needs" * 100 = "Care Coordinator Was DEFINITELY Knowledgeable, Supportive and Advocated for Child's Needs." This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=35 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
n=24 Participants
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Family Experiences With Care Coordination (FECC): Care Coordination Question Set
|
87.3 score on a scale
Standard Deviation 19.1
|
94.2 score on a scale
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsMotivation is assessed by the confidence response to weekly texting and averaged over time by participant. (1-10 with higher scores indicating increased confidence). This Outcome Measure was assessed in dyads.
Outcome measures
| Measure |
RE-PACT Intervention + Active Control (AC)
n=36 Participants
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
AC subjects will receive usual comprehensive medical care and coordination.
\*Recruitment duration was not stratified by arm.
|
Active Control (AC)
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Average Confidence Responses Reported by mHealth Texting
|
8.59 score on a scale
Standard Deviation 1.62
|
—
|
Adverse Events
RE-PACT Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control (AC)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RE-PACT Intervention
n=36 participants at risk
Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.
RE-PACT Intervention:
* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching
|
Active Control (AC)
n=24 participants at risk
AC subjects will receive usual comprehensive medical care and coordination.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/36 • Adverse event data was collected during active study participation (from 4/14/2022 to 2/14/2024); any reportable events are followed to completion. Participants were assessed from enrollment to study exit, an average of six months. Caregivers were not followed for adverse events.
Per protocol, information indicating an undesirable experience with study participation was reported to PI to determine if it's associated with the study. Associated events were reported to the IRB per local guidelines: https://irb.wisc.edu/wp-content/uploads/sites/2/sites/2/2022/07/AEdecisionguidewithFDAVAupdate\_10\_31\_17.pdf. Additionally, events are documented in study files as Note-to-File. All SAEs and study-associated AEs are reported. Non-study related AEs were not collected or reported.
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected during active study participation (from 4/14/2022 to 2/14/2024); any reportable events are followed to completion. Participants were assessed from enrollment to study exit, an average of six months. Caregivers were not followed for adverse events.
Per protocol, information indicating an undesirable experience with study participation was reported to PI to determine if it's associated with the study. Associated events were reported to the IRB per local guidelines: https://irb.wisc.edu/wp-content/uploads/sites/2/sites/2/2022/07/AEdecisionguidewithFDAVAupdate\_10\_31\_17.pdf. Additionally, events are documented in study files as Note-to-File. All SAEs and study-associated AEs are reported. Non-study related AEs were not collected or reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ryan Coller
University of Wisconsin School of Medicine and Public Health
Phone: 608-263-9408
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place