Diabetes Mellitus, Type 2MINCT03985098
Motivational Interviewing (MI) Intervention to Improve Adherence
A study testing Motivational interviewing intervention arm in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Houston at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a telephone motivational interviewing intervention by pharmacy students in enhancing adherence to angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) (ACE/ARBs) among patients with diabetes and hypertension in a Medicare… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Motivational interviewing intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 727 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 22 Mar 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Continuous enrollment over the study period July 2016 to December 2018.
- A prescription filled for an ACEI or ARB medication between July 1st, 2017- December 31st, 2017. This will be defined as the index date (for phase 1).
- Diagnosis of both DM and HTN prior to index date, identified through the health plan's medical claims program (CCMS) using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes only.
Who cannot join
- Disenrollment from drug plan.
- Death prior to end of the study.
- Having a diagnosis of dementia in the one-year pre-index period.
- Having an ACEI/ARB contraindication like angioedema, hyperkalemia, and renal artery stenosis in the one-year pre-index period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Motivational Interviewing Intervention Customized by Patient Adherence Patterns
The purpose of this study is to examine the effectiveness of a telephone motivational interviewing intervention by pharmacy students in enhancing adherence to angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) (ACE/ARBs) among patients with diabetes and hypertension in a Medicare advantage plan.
Read the detailed description
Angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) are highly recommended for patients with both diabetes (DM) and hypertension (HTN), and their efficacy in reducing macrovascular and microvascular complications of DM is well-documented. Poor adherence remains a significant barrier to achieving full effectiveness and optimal long-term outcomes. This study aims to develop innovative group-based trajectory models to identify patients with similar ACE/ARB medication filling behavior among patients with co-morbid HTN and DM. The proportion of days covered (PDC), often used as an adherence measure, reduces complex patterns of longitudinal observations into a single value that cannot adequately depict different adherence experiences. Group based trajectory models are designed to identify patients with similar longitudinal patterns while capturing the dynamic nature. A motivational interviewing (MI) pharmacy student telephone intervention will then be customized by the identified trajectories and tested to demonstrate effectiveness in enhancing adherence. In pilot work, the investigator's team has demonstrated improvements in adherence through a pharmacy student telephone MI intervention. Pharmacy students have the knowledge base and training to provide comparable services to pharmacists at a lower cost. MI fosters behavior change by setting desired goals and promoting self-efficacy in a supportive, collaborative way. The objectives are to 1. Develop group-based trajectory models to identify patients with similar medication filling behavior patterns among patients enrolled in a Medicare advantage plan and 2. Customize an MI pharmacy student telephone intervention by the adherence patterns identified, and demonstrate the benefit of the customized intervention in improving adherence. Phase 1 of the project will be a retrospective analysis of 12 month refill data to determine patient adherence patterns. Phase 2 will be a prospective study among non-adherent patients to evaluate the effectiveness of the customized intervention (n=500). The students will contact patients assigned to the intervention group and follow a protocol using the Ask-Provide-Ask approach of MI given the patient adherence pattern for a tailored education. Monthly follow-up calls will be carried out for 6 months. Adherence during the 6 and 12 months post-intervention will be evaluated for the intervention and control groups as PDC as well as a categorical variable. Chi-square and t-tests will be used to evaluate the intervention effect. Multivariable multiple and logistic regression will be carried out in case of any significant differences in baseline characteristics. Implementing this project will provide students a unique MI training as a new way of communicating with patients. The training is further strengthened by PhD students trained in research design and statistical analyses to assist in the automated data analysis. The project will formulate a strong adherence research team at University of Houston that will be instrumental in implementing customized innovative interventions to improve medication adherence and subsequent health outcomes.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Motivational interviewing intervention arm
- Keywords
- Motivational interviewing, trajectory modeling, medication adherence
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing intervention armBehavioural
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing intervention arm | Experimental | The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls Receives: Behavioral: Motivational interviewing intervention arm |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Measure
Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
Measured: 12 months following initial call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start29 May 2019
- Primary completion22 Mar 2021
- Study completion22 Mar 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Susan Abughosh,, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985098
- Sponsor's protocol ID
- STUDY00000718
- Other IDs
- R15HL135700-01A1
- Acronym
- MI
- Status last verified
- May 2023
- First submitted
- 10 Jun 2019
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohan A, Majd Z, Johnson ML, Essien EJ, Barner J, Serna O, Gallardo E, Fleming ML, Ordonez N, Holstad MM, Abughosh SM. A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes. Drugs Aging. 2023 Apr;40(4):377-390. doi: 10.1007/s40266-023-01008-6. Epub 2023 Feb 27.
PubMed 36847995
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Motivational Interviewing Intervention Customized by Patient Adherence Patterns
- ClinicalTrials.gov ID
- NCT03985098
- Acronym / sponsor ID
- MI / STUDY00000718
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Motivational interviewing, trajectory modeling, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effectiveness of a telephone motivational interviewing intervention by pharmacy students in enhancing adherence to angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) (ACE/ARBs) among patients with diabetes and hypertension in a Medicare advantage plan.
Detailed description
Angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) are highly recommended for patients with both diabetes (DM) and hypertension (HTN), and their efficacy in reducing macrovascular and microvascular complications of DM is well-documented. Poor adherence remains a significant barrier to achieving full effectiveness and optimal long-term outcomes. This study aims to develop innovative group-based trajectory models to identify patients with similar ACE/ARB medication filling behavior among patients with co-morbid HTN and DM. The proportion of days covered (PDC), often used as an adherence measure, reduces complex patterns of longitudinal observations into a single value that cannot adequately depict different adherence experiences. Group based trajectory models are designed to identify patients with similar longitudinal patterns while capturing the dynamic nature. A motivational interviewing (MI) pharmacy student telephone intervention will then be customized by the identified trajectories and tested to demonstrate effectiveness in enhancing adherence. In pilot work, the investigator's team has demonstrated improvements in adherence through a pharmacy student telephone MI intervention. Pharmacy students have the knowledge base and training to provide comparable services to pharmacists at a lower cost. MI fosters behavior change by setting desired goals and promoting self-efficacy in a supportive, collaborative way. The objectives are to 1. Develop group-based trajectory models to identify patients with similar medication filling behavior patterns among patients enrolled in a Medicare advantage plan and 2. Customize an MI pharmacy student telephone intervention by the adherence patterns identified, and demonstrate the benefit of the customized intervention in improving adherence. Phase 1 of the project will be a retrospective analysis of 12 month refill data to determine patient adherence patterns. Phase 2 will be a prospective study among non-adherent patients to evaluate the effectiveness of the customized intervention (n=500). The students will contact patients assigned to the intervention group and follow a protocol using the Ask-Provide-Ask approach of MI given the patient adherence pattern for a tailored education. Monthly follow-up calls will be carried out for 6 months. Adherence during the 6 and 12 months post-intervention will be evaluated for the intervention and control groups as PDC as well as a categorical variable. Chi-square and t-tests will be used to evaluate the intervention effect. Multivariable multiple and logistic regression will be carried out in case of any significant differences in baseline characteristics. Implementing this project will provide students a unique MI training as a new way of communicating with patients. The training is further strengthened by PhD students trained in research design and statistical analyses to assist in the automated data analysis. The project will formulate a strong adherence research team at University of Houston that will be instrumental in implementing customized innovative interventions to improve medication adherence and subsequent health outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing intervention arm | Experimental | Behavioral: Motivational interviewing intervention armThe intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls |
| Control | No intervention | –usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Continuous enrollment over the study period July 2016 to December 2018.
- A prescription filled for an ACEI or ARB medication between July 1st, 2017- December 31st, 2017. This will be defined as the index date (for phase 1).
- Diagnosis of both DM and HTN prior to index date, identified through the health plan's medical claims program (CCMS) using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes only.
Key exclusion criteria (4 listed)
- Disenrollment from drug plan.
- Death prior to end of the study.
- Having a diagnosis of dementia in the one-year pre-index period.
- Having an ACEI/ARB contraindication like angioedema, hyperkalemia, and renal artery stenosis in the one-year pre-index period.
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 |
|---|---|---|
| Motivational interviewing intervention armThe intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls | Behavioural | Motivational interviewing intervention arm |
Primary outcome
Adherence Measure
Time frame: 12 months following initial call
Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36847995Mohan A, Majd Z, Johnson ML, Essien EJ, Barner J, Serna O, Gallardo E, Fleming ML, Ordonez N, Holstad MM, Abughosh SM. A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes. Drugs Aging. 2023 Apr;40(4):377-390. doi: 10.1007/s40266-023-01008-6. Epub 2023 Feb 27.
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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.
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 Motivational interviewing intervention arm in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Houston 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 3 inclusion and 4 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 15 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2023). 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?
Adherence Measure (time frame: 12 months following initial call). 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 NCT03985098, which also lists 1 linked publication.
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 15 Jun 2023.