Trial Outcomes & Findings for Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis (NCT NCT02301377)
NCT ID: NCT02301377
Last Updated: 2015-07-16
Results Overview
Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
3 months
Results posted on
2015-07-16
Participant Flow
Participant milestones
| Measure |
Intervention Group
Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
|
Control
Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Intervention Group
n=3 Participants
Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
|
Control
n=2 Participants
Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.51 years
STANDARD_DEVIATION 0.64 • n=5 Participants
|
11.93 years
STANDARD_DEVIATION 1.29 • n=7 Participants
|
11.67 years
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Forced expiratory volume in 1 second (FEV1)
|
74.33 %predicted
STANDARD_DEVIATION 16.65 • n=5 Participants
|
93 %predicted
STANDARD_DEVIATION 1.41 • n=7 Participants
|
81.8 %predicted
STANDARD_DEVIATION 15.61 • n=5 Participants
|
|
Body Mass Index (BMI) Percentile
|
64.33 Percentile
STANDARD_DEVIATION 19.14 • n=5 Participants
|
41.5 Percentile
STANDARD_DEVIATION 16.26 • n=7 Participants
|
55.2 Percentile
STANDARD_DEVIATION 20.14 • n=5 Participants
|
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Child)
|
74.33 units on a scale
STANDARD_DEVIATION 6.35 • n=5 Participants
|
78 units on a scale
STANDARD_DEVIATION 31.11 • n=7 Participants
|
75.8 units on a scale
STANDARD_DEVIATION 16.31 • n=5 Participants
|
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain (Parent)
|
59.33 units on a scale
STANDARD_DEVIATION 17.24 • n=5 Participants
|
61 units on a scale
STANDARD_DEVIATION 24.04 • n=7 Participants
|
60 units on a scale
STANDARD_DEVIATION 17.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOverall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.
Outcome measures
| Measure |
Control
n=2 Participants
Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
|
Intervention Group
n=3 Participants
Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
|
|---|---|---|
|
Medication Adherence
|
100 Percent Adherence
Standard Deviation 0
|
91.6 Percent Adherence
Standard Deviation 14.43
|
SECONDARY outcome
Timeframe: 3 monthsResponse of the participants to the treatment burden domain of the CFQ-R at the end of 3 months
Outcome measures
| Measure |
Control
n=2 Participants
Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
|
Intervention Group
n=3 Participants
Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
|
|---|---|---|
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)
|
72.5 units on a scale
Standard Deviation 23.33
|
81.66 units on a scale
Standard Deviation 16.80
|
SECONDARY outcome
Timeframe: 3 monthsResponse of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months
Outcome measures
| Measure |
Control
n=2 Participants
Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
|
Intervention Group
n=3 Participants
Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
|
|---|---|---|
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)
|
66.5 units on a scale
Standard Deviation 31.82
|
67 units on a scale
Standard Deviation 19.05
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place