Trial Outcomes & Findings for Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study (NCT NCT04908384)

Results Overview

10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	IMPACT Intervention Child Participants IMPACT health application and wearable device - child participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device	IMPACT Intervention - Parent Participants IMPACT health application and wearable device - parent participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device	Usual Care Control Child Participants Usual care control - child participants	Usual Care Control Parent Participants Usual care control - parent participants
Overall Study STARTED	21	21	31	31
Overall Study COMPLETED	17	17	31	31
Overall Study NOT COMPLETED	4	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IMPACT Intervention Child Participants IMPACT health application and wearable device - child participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device	IMPACT Intervention - Parent Participants IMPACT health application and wearable device - parent participants Improving Asthma Care Together (IMPACT): IMPACT is a novel health application and wearable device	Usual Care Control Child Participants Usual care control - child participants	Usual Care Control Parent Participants Usual care control - parent participants
Overall Study Lost to Follow-up	4	4	0	0

Baseline Characteristics

Only measured spirometry in child participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMPACT Intervention Child Participants n=21 Participants IMPACT health application and wearable device - child participants	IMPACT Intervention Parent Participants n=21 Participants IMPACT health application and wearable device - parent participants	Usual Care Control Child Participants n=31 Participants Usual care control - child participants	Usual Care Control Parent Participants n=31 Participants Usual care control - parent participants	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=21 Participants	0 Participants n=21 Participants	31 Participants n=31 Participants	0 Participants n=31 Participants	52 Participants n=104 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=21 Participants	21 Participants n=21 Participants	0 Participants n=31 Participants	31 Participants n=31 Participants	52 Participants n=104 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=104 Participants
Sex: Female, Male Female	10 Participants n=21 Participants	20 Participants n=21 Participants	17 Participants n=31 Participants	29 Participants n=31 Participants	76 Participants n=104 Participants
Sex: Female, Male Male	11 Participants n=21 Participants	1 Participants n=21 Participants	14 Participants n=31 Participants	2 Participants n=31 Participants	28 Participants n=104 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=21 Participants	4 Participants n=21 Participants	6 Participants n=31 Participants	6 Participants n=31 Participants	21 Participants n=104 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=21 Participants	17 Participants n=21 Participants	25 Participants n=31 Participants	25 Participants n=31 Participants	83 Participants n=104 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=104 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=104 Participants
Race (NIH/OMB) Asian	1 Participants n=21 Participants	3 Participants n=21 Participants	1 Participants n=31 Participants	2 Participants n=31 Participants	7 Participants n=104 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants	1 Participants n=31 Participants	1 Participants n=104 Participants
Race (NIH/OMB) Black or African American	2 Participants n=21 Participants	1 Participants n=21 Participants	7 Participants n=31 Participants	6 Participants n=31 Participants	16 Participants n=104 Participants
Race (NIH/OMB) White	9 Participants n=21 Participants	14 Participants n=21 Participants	15 Participants n=31 Participants	17 Participants n=31 Participants	55 Participants n=104 Participants
Race (NIH/OMB) More than one race	8 Participants n=21 Participants	1 Participants n=21 Participants	7 Participants n=31 Participants	3 Participants n=31 Participants	19 Participants n=104 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=21 Participants	2 Participants n=21 Participants	1 Participants n=31 Participants	2 Participants n=31 Participants	6 Participants n=104 Participants
Asthma Responsibility Questionnaire	2.74 units on a scale STANDARD_DEVIATION .55 • n=21 Participants	2.4 units on a scale STANDARD_DEVIATION .61 • n=21 Participants	2.69 units on a scale STANDARD_DEVIATION .54 • n=31 Participants	2.3 units on a scale STANDARD_DEVIATION .7 • n=31 Participants	2.5 units on a scale STANDARD_DEVIATION .51 • n=104 Participants
Spirometry - FEV1/FVC	85.7 percent of predicted STANDARD_DEVIATION 10.5 • n=21 Participants • Only measured spirometry in child participants.	—	78.6 percent of predicted STANDARD_DEVIATION 13.4 • n=31 Participants • Only measured spirometry in child participants.	—	82.9 percent of predicted STANDARD_DEVIATION 12.1 • n=52 Participants • Only measured spirometry in child participants.
Childhood asthma control test	19.8 units on a scale STANDARD_DEVIATION 3.19 • n=21 Participants • Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.	—	21.39 units on a scale STANDARD_DEVIATION 2.65 • n=31 Participants • Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.	—	20.8 units on a scale STANDARD_DEVIATION 2.96 • n=52 Participants • Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.
Asthma Quality of Life	5.67 units on a scale STANDARD_DEVIATION .99 • n=21 Participants	5.6 units on a scale STANDARD_DEVIATION .95 • n=21 Participants	5.88 units on a scale STANDARD_DEVIATION .57 • n=31 Participants	5.8 units on a scale STANDARD_DEVIATION .85 • n=31 Participants	5.7 units on a scale STANDARD_DEVIATION .61 • n=104 Participants
Medication Adherence	3.7 units on a scale STANDARD_DEVIATION .78 • n=21 Participants	4.1 units on a scale STANDARD_DEVIATION .79 • n=21 Participants	3.8 units on a scale STANDARD_DEVIATION .75 • n=31 Participants	4.0 units on a scale STANDARD_DEVIATION .62 • n=31 Participants	3.9 units on a scale STANDARD_DEVIATION .6 • n=104 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=21 Participants Child participants assigned to intervention group	Parent Intervention Group n=21 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks	2.72 score on a scale Standard Error .14	2.72 score on a scale Standard Error .11	2.79 score on a scale Standard Error .1	2.31 score on a scale Standard Error .08

PRIMARY outcome

Timeframe: 8 and 16 weeks

10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=17 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Asthma Responsibility Questionnaire Change From 8 to 16 Weeks	2.88 score on a scale Standard Error .13	2.63 score on a scale Standard Error .13	2.90 score on a scale Standard Error .1	2.4 score on a scale Standard Error .1

PRIMARY outcome

Timeframe: Baseline and 8 weeks

13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=19 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Asthma Management Self-efficacy Change From Baseline to 8 Weeks	3.79 score on a scale Standard Error .11	4.27 score on a scale Standard Error .09	3.74 score on a scale Standard Error .08	4.41 score on a scale Standard Error .07

PRIMARY outcome

Timeframe: 8 and 16 weeks

13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=17 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks	3.69 score on a scale Standard Error .12	4.36 score on a scale Standard Error .1	3.49 score on a scale Standard Error .09	4.52 score on a scale Standard Error .08

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Spirometry - FEV1/FVC Change From Baseline to 8 Weeks	85.18 percentage of predicted Standard Error 3.35	82.87 percentage of predicted Standard Error 2.39	—	—

SECONDARY outcome

Timeframe: 8 and 16 weeks

Spirometry - objective measure of expiratory lung function will be used to evaluate asthma control. Specifically, the forced expiratory volume in one second/forced vital capacity (FEV1/FVC) measure will be used and interpreted according to the national spirometry guideline cutpoints (NAEPP EPR4 report). Scores are presented as a percentage and typically range from 1% to 120% (occasionally higher), with higher scores indicating better asthma control. Note, national asthma guidelines consider \>85% to indicate well controlled asthma.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks	85.38 percentage of predicted Standard Error 2.42	81.82 percentage of predicted Standard Error 1.73	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.

7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Childhood Asthma Control Test Change From Baseline to 8 Weeks	12.46 score on a scale Standard Error .37	12.78 score on a scale Standard Error .28	—	—

SECONDARY outcome

Timeframe: 8 and 16 weeks

Population: Scale uses a combination of child and parent participants scores for an overall asthma control score. Overall scores reported under child participants.

7 total items--3 parent (5-point scale) and 4 child (3-point scale) to assess asthma control. Parent and child scores are summed, possible range of 7-27, with higher scores indicate better control. One total score reported for child participants.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks	12.93 score on a scale Standard Error .58	12.14 score on a scale Standard Error .43	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Childhood Asthma Quality of Life Change From Baseline to 8 Weeks	5.74 score on a scale Standard Error .15	5.97 score on a scale Standard Error .11	—	—

SECONDARY outcome

Timeframe: 8 and 16 weeks

Self-report child (13 items)- asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Possible score range of 1-7.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks	5.56 score on a scale Standard Error .16	5.98 score on a scale Standard Error .12	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable.

Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-43.35, with higher scores indicating worse quality of life.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Parent Asthma Quality of Life Change From Baseline to 8 Weeks	11.56 score on a scale Standard Error 2.7	7.08 score on a scale Standard Error 1.27	—	—

SECONDARY outcome

Timeframe: 8 and 16 weeks

Population: Means and SEs for this variable reflect an exponential transformation to compensate for a negatively skewed distribution in the raw variable.

Parent/caregiver (13 items)-reported asthma quality of life, scores range from 1-7 per item, a mean of item scores calculated, with higher scores indicating better quality of life. Score range of variable, which required exponential transformation for negatively skewed distribution, was 2.72-345.90, with higher scores indicating worse quality of life.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=31 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks	12.85 score on a scale Standard Error 3.29	17.44 score on a scale Standard Error 10.99	—	—

SECONDARY outcome

Timeframe: 8 weeks

Population: Child max score of 10; parent max score of 20

4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher acceptability. Possible score range of 4-20 for parents, 2-10 for children.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=19 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Acceptability of Intervention Measure (Intervention Groups Only)	8 score on a scale Standard Deviation 1.26	14.42 score on a scale Standard Deviation 3.62	—	—

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=19 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Medication Adherence Change From Baseline to 8 Weeks	3.20 score on a scale Standard Error .53	3.30 score on a scale Standard Error .44	3.70 score on a scale Standard Error .39	3.25 score on a scale Standard Error .32

SECONDARY outcome

Timeframe: 8 and 16 weeks

Medication Adherence Report Scale for Asthma, 10-items, 5-point scale assessing reported child asthma controller medication adherence at baseline and throughout the study. Higher adherence suggests better asthma management. Scores are averaged, ranging from 1-5, with higher scores indicating better adherence.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=17 Participants Child participants assigned to intervention group	Parent Intervention Group n=17 Participants Parents assigned to intervention group	Child Control Group n=31 Participants Child participants assigned to control group	Parent Control Group n=31 Participants Parent participants assigned to control group
Medication Adherence Change From 8 Weeks to 16 Weeks	3.32 score on a scale Standard Error .65	3.04 score on a scale Standard Error .45	3.78 score on a scale Standard Error .48	3.65 score on a scale Standard Error .33

SECONDARY outcome

Timeframe: 8 weeks

Population: child score max of 10; parent max score of 20

4 items (2 for children) using 5-point scale; scores are summed with higher scores indicate higher feasibility. Possible score range of 4-20 for parents, 2-10 for children.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=19 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
Feasibility of Intervention (Intervention Group Only)	8 score on a scale Standard Deviation 1.17	14.37 score on a scale Standard Deviation 3.36	—	—

SECONDARY outcome

Timeframe: 8 weeks

System usability scale - 10 items, 5-point scale to determine perceived usability of a system. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of SU. Total score may range from 0 to 100 with higher scores indicating higher usability. Used only post-intervention.

Outcome measures

Outcome measures
Measure	Child Intervention Group n=19 Participants Child participants assigned to intervention group	Parent Intervention Group n=19 Participants Parents assigned to intervention group	Child Control Group Child participants assigned to control group	Parent Control Group Parent participants assigned to control group
System Usability Scale (Intervention Group Only)	68.95 score on a scale Standard Deviation 14.03	62.5 score on a scale Standard Deviation 19.18	—	—

Adverse Events

IMPACT Intervention - Child Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IMPACT Intervention - Parent Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Control - Child Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Control - Parent Participants

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

Jennifer Sonney

University of Washington

Phone: 206-685-2161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place