AsthmaNCT00414817
Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
A study testing Automated Phone-Based Refill Reminders in people with Asthma, run by Kaiser Permanente at 2 sites in United States.
Trial summary
Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Automated Phone-Based Refill Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,064 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received treatment for asthma in the year prior to study entry
- Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry
- Continuous Kaiser Permanente membership from the year prior to study entry through study entry
- Willing to participate in the study
Who cannot join
- Excluded from primary analyses if fewer than three months of follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Health Research/KPH
Honolulu, Hawaii, 96817
Center for Health Research-KPNW
Portland, Oregon, 97227
About this study
Official title: Phone Calls to Promote Adherence With Inhaled Corticosteroids
Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.
Read the detailed description
Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.
This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.
- Conditions
- Asthma
- Being tested
- Automated Phone-Based Refill Reminders
- Keywords
- Inhaled Corticosteroids, ICS, Adherence
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Phone-Based Refill RemindersBehavioural
Also called The BREATHE EASY Medication Reminder Program
The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.
| Study group | Role | What they receive |
|---|---|---|
| Automated Phone-Based Refill Reminders | Experimental | Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. Receives: Behavioral: Automated Phone-Based Refill Reminders |
| Usual Care | No intervention | Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medication Possession Ratio
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.
Measured: Measured over 19 months
Secondary outcomes (2)
Juniper Asthma Quality of Life Questionnaire (Global Score)
Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.
Measured: Measured at 19 months
Rate of Acute Health Care Visits for Asthma
annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.
Measured: Measured over 19 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William M. Vollmer, PhD, Principal investigator, Center for Health Research/KPNWCynthia Rand, PhD, Principal investigator, Johns Hopkins UniversityJoan Dubanoski, PhD, Principal investigator, Center for Health Research/KPHAdrianne Feldstein, MD, Principal investigator, Center for Health Research/KPNWDavid Smith, PhD, Principal investigator, Center for Health Research/KPNW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414817
- Sponsor's protocol ID
- 443
- Other IDs
- R01HL083433, R01HL083433-01A1
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2006
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vollmer WM, Xu M, Feldstein A, Smith D, Waterbury A, Rand C. Comparison of pharmacy-based measures of medication adherence. BMC Health Serv Res. 2012 Jun 12;12:155. doi: 10.1186/1472-6963-12-155.
PubMed 22691240Vollmer WM, Feldstein A, Smith DH, Dubanoski JP, Waterbury A, Schneider JL, Clark SA, Rand C. Use of health information technology to improve medication adherence. Am J Manag Care. 2011 Dec;17(12 Spec No.):SP79-87.
PubMed 22216772Schneider J, Waterbury A, Feldstein A, Donovan J, Vollmer WM, Dubanoski J, Clark S, Rand C. Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach. Health Informatics J. 2011 Mar;17(1):72-88. doi: 10.1177/1460458210391220.
PubMed 25133772
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Calls to Promote Adherence With Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT00414817
- Acronym / sponsor ID
- 443
- Conditions
- Asthma
- Keywords
- Inhaled Corticosteroids, ICS, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,064 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Posted 30 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.
Detailed description
Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.
This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Phone-Based Refill Reminders | Experimental | Behavioral: Automated Phone-Based Refill RemindersIntervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period. |
| Usual Care | No intervention | –Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the "usual care" study arm, and therefore, receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Received treatment for asthma in the year prior to study entry
- Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry
- Continuous Kaiser Permanente membership from the year prior to study entry through study entry
- Willing to participate in the study
Key exclusion criteria (1 listed)
- Excluded from primary analyses if fewer than three months of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Phone-Based Refill RemindersAlso: The BREATHE EASY Medication Reminder ProgramThe BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions. | Behavioural | Automated Phone-Based Refill Reminders |
Primary outcome
Modified Medication Possession Ratio
Time frame: Measured over 19 months
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.
2 secondary outcomes
Juniper Asthma Quality of Life Questionnaire (Global Score)
Time frame: Measured at 19 months
Rate of Acute Health Care Visits for Asthma
Time frame: Measured over 19 months of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22691240Vollmer WM, Xu M, Feldstein A, Smith D, Waterbury A, Rand C. Comparison of pharmacy-based measures of medication adherence. BMC Health Serv Res. 2012 Jun 12;12:155. doi: 10.1186/1472-6963-12-155.
- Results publication: PubMed 22216772Vollmer WM, Feldstein A, Smith DH, Dubanoski JP, Waterbury A, Schneider JL, Clark SA, Rand C. Use of health information technology to improve medication adherence. Am J Manag Care. 2011 Dec;17(12 Spec No.):SP79-87.
- Results publication: PubMed 25133772Schneider J, Waterbury A, Feldstein A, Donovan J, Vollmer WM, Dubanoski J, Clark S, Rand C. Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach. Health Informatics J. 2011 Mar;17(1):72-88. doi: 10.1177/1460458210391220.
- main outcomes, Amer J Manag Care 2011Link provided by the sponsor.
- Vollmer et al, BMC Hlth Serv Res 2012. contains further details on computation of primary outcome measure and its performance characteristicsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M. Vollmer, PhD principal investigator
Center for Health Research/KPNW
Cynthia Rand, PhD principal investigator
Johns Hopkins University
Joan Dubanoski, PhD principal investigator
Center for Health Research/KPH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Phone-Based Refill Reminders in people with Asthma, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medication Possession Ratio (time frame: Measured over 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414817, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.