TreatmentMAPNCT00838344
The Medication Adherence Program
A study testing Medication Adherence Program (MAP) in people with Treatment and Diabetes, run by University of Washington at 1 site in United States.
Trial summary
In this study, the investigators will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care progress, and provide intervention to resolve any… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Medication Adherence Program (MAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 or older with type 2 diabetes on at least one oral diabetes medication who have missed a refill by 6 or more days
Who cannot join
- Those unable to converse in the same language as their usual care Safeway pharmacist (Spanish or English most common languages spoken at the site stores) or who do not have an interpreter, family member, friend, or caregiver who can act on the subject's behalf as an interpreter during the initial or any follow-up phone calls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Medication Adherence Program:Promoting Diabetes Self-Management Through Community Pharmacies
In this study, the investigators will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care progress, and provide intervention to resolve any barriers to taking prescribed medicines. The hypothesis for the study is that personalized telephone follow-up by a pharmacist will assist people who have missed refilling their prescriptions in taking diabetes medicines by resolving medication adherence challenges. Following randomization, the intervention will be offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for prescribed DM medicine refills by at least 6 days. Control subjects will receive usual pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide medication adherence support to intervention subjects for 12 months following enrollment with the goal of improving medication refilling and persistence.
Read the detailed description
Taking medicines can be a challenge for those with diabetes mellitus (DM) with adherence rates to DM medicines as low as 31%. Adherence to DM medicines improves DM by reducing blood glucose (ie A1c reduction) but will also result in improved outcomes, reduced cardiovascular risks, and reduced costs of diabetes. The most common factors reported to affect medication taking in those with DM include difficulty remembering refills and doses, regimen complexity (e.g more than one DM drug, need to split tablets, mix products), dosing frequency greater than twice daily, depression, and adverse effects or fear of them.
Pharmacists have immense opportunity to interact with people with DM, who now number over 20 million in the United States (US). This reality is due to several factors including convenience of pharmacies (found in most urban, suburban, and rural communities), accessibility of pharmacists for questions and counseling (appointments not usually required), and strong rapport that pharmacists and their staff develop with long-term patients and their families through their presence in the community. Pharmacists in community practices work directly with patients and review refill information about patient medication use thus allowing for personalized, immediate, and ongoing promotion of adherence. Currently, pharmacists do not routinely call patients who are overdue for prescription refills to ascertain if the refill is still needed or proactively work to resolve any barriers to refilling. The standard of care is to provide refill and medication adherence support if it is requested by a patient and if the pharmacy is able to provide the needed level of support.
In this study, we will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call by a pharmacist to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines and provide intervention to resolve any barriers.
- Being tested
- Medication Adherence Program (MAP)
- Keywords
- medication adherence, medication persistence, pharmacist interventions, diabetes, persistence, adherence
- Medical subject headings
- Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Adherence Program (MAP)Other
Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual prescription refill system and pharmacy care. |
| Intervention | Experimental | Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers. Receives: Other: Medication Adherence Program (MAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
Measured: 12 months
Secondary outcomes (1)
medication adherence challenges
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionJan 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Diabetes Educators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838344
- Sponsor's protocol ID
- 33084-D
- Other IDs
- 07-9030-D-01, RFA0100-06
- Acronym
- MAP
- Status last verified
- Sep 2009
- First submitted
- 5 Feb 2009
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medication Adherence Program:Promoting Diabetes Self-Management Through Community Pharmacies
- ClinicalTrials.gov ID
- NCT00838344
- Acronym / sponsor ID
- MAP / 33084-D
- Keywords
- medication adherence, medication persistence, pharmacist interventions, diabetes, persistence, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- American Association of Diabetes Educators
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care progress, and provide intervention to resolve any barriers to taking prescribed medicines. The hypothesis for the study is that personalized telephone follow-up by a pharmacist will assist people who have missed refilling their prescriptions in taking diabetes medicines by resolving medication adherence challenges. Following randomization, the intervention will be offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for prescribed DM medicine refills by at least 6 days. Control subjects will receive usual pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide medication adherence support to intervention subjects for 12 months following enrollment with the goal of improving medication refilling and persistence.
Detailed description
Taking medicines can be a challenge for those with diabetes mellitus (DM) with adherence rates to DM medicines as low as 31%. Adherence to DM medicines improves DM by reducing blood glucose (ie A1c reduction) but will also result in improved outcomes, reduced cardiovascular risks, and reduced costs of diabetes. The most common factors reported to affect medication taking in those with DM include difficulty remembering refills and doses, regimen complexity (e.g more than one DM drug, need to split tablets, mix products), dosing frequency greater than twice daily, depression, and adverse effects or fear of them.
Pharmacists have immense opportunity to interact with people with DM, who now number over 20 million in the United States (US). This reality is due to several factors including convenience of pharmacies (found in most urban, suburban, and rural communities), accessibility of pharmacists for questions and counseling (appointments not usually required), and strong rapport that pharmacists and their staff develop with long-term patients and their families through their presence in the community. Pharmacists in community practices work directly with patients and review refill information about patient medication use thus allowing for personalized, immediate, and ongoing promotion of adherence. Currently, pharmacists do not routinely call patients who are overdue for prescription refills to ascertain if the refill is still needed or proactively work to resolve any barriers to refilling. The standard of care is to provide refill and medication adherence support if it is requested by a patient and if the pharmacy is able to provide the needed level of support.
In this study, we will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call by a pharmacist to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines and provide intervention to resolve any barriers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual prescription refill system and pharmacy care. |
| Intervention | Experimental | Other: Medication Adherence Program (MAP)Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 or older with type 2 diabetes on at least one oral diabetes medication who have missed a refill by 6 or more days
Key exclusion criteria (1 listed)
- Those unable to converse in the same language as their usual care Safeway pharmacist (Spanish or English most common languages spoken at the site stores) or who do not have an interpreter, family member, friend, or caregiver who can act on the subject's behalf as an interpreter during the initial or any follow-up phone calls
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 |
|---|---|---|
| Medication Adherence Program (MAP)Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days. Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers. | Other | Intervention |
Primary outcome
medication adherence
Time frame: 12 months
1 secondary outcome
medication adherence challenges
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
Related trials for Treatment
Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Bladder Cancer, TURBT
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Irritability Associated With Autism Spectrum Disorder
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Adherence Program (MAP) in people with Treatment and Diabetes, run by University of Washington at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
medication adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2009.