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Coronary Artery DiseaseNCT02480530

Using Feedback Reports to Improve Medication Adherence

A study testing Individual Feedback and Feedback Friend in people with Coronary Artery Disease and Adherence, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to improve statin medication adherence among Veterans with coronary artery disease with poor adherence to medications. The investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication… Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease, Adherence
What is being tested?
Individual Feedback and Feedback Friend
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
Jan 2014to 3 Sep 2015
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 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants will have a diagnosis of CAD
  • To be eligible they must be between the ages of 30-75 years of age-to ensure we are targeting those most likely to benefit from improving control to these medications
  • Patients must have been prescribed a statin by their provider and a documented poor adherence as measured by a 16-month medication adherence rate (Medication Possession Ratio) of <80%

Who cannot join

  • Due to the use of the medication adherence reminder device, patients must speak English
  • Have a home address
  • Telephone number
  • Be willing and able to identify a friend or family member
  • The investigators will exclude atients with active substance abuse, significant hearing loss, or reduced cognitive ability as determined from the patient's problem list

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Philadelphia VA Medical Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease

The purpose of this research study is to improve statin medication adherence among Veterans with coronary artery disease with poor adherence to medications. The investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication taking behavior.

Read the detailed description

Patients with coronary artery disease and previous poor adherence to statin medications will be recruited at Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to one of three arms:

  1. Control Group
  2. Individual Alarm device and feedback report
  3. Individual plus patient-selected Feedback Friend report

Patients will be given a medication-monitoring device (Vitality GlowCaps) to monitor the statin medication that is being currently prescribed by their primary care physician. In first group, the control arm (Arm 1), the device reminders will be turned off but the device will continue recording adherence to the medications. In second group, reminder arm (Arm 2), the device will be programmed as an alarm that will be activated if the patient does not take the medication at the time set by the patient. In addition the patient will get a weekly report of his/her adherence. In the third group, patient-selected family/friend/or reciprocal peer feedback arm (Arm 3), in addition to the activation of the alarm function the device will be linked to a weekly report on adherence to medications. This report will be delivered to the patient and to the patient identified family/friend/ or reciprocal peer.

Being tested
Individual Feedback, Feedback Friend
Keywords
Medication Adherence, Reciprocal Peer, Telemonitoring
Medical subject headings
Coronary Artery Disease, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual FeedbackBehavioural

    Patient gets feedback reports on adherence weekly.

  • Feedback FriendBehavioural

    In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.

Study groups in NCT02480530
Study groupRoleWhat they receive
ControlNo interventionPatients will be given educational material on the importance of adherence to statin medications. The GlowCaps device will be set to only record adherence.
Individual FeedbackExperimentalIn addition to educational material on adherence to statin medications, the research coordinator will review set-up of personal reminders for the GlowCaps device which will be set to glow and buzz when the medication is missed. In addition, patients will receive information on the weekly adherence feedback report.
Receives: Behavioral: Individual Feedback
Feedback FriendExperimentalThe patient will be given educational material on the importance of adhering to statin medications. The research coordinator will review set-up of alarm features of GlowCaps device. Similar to Arm 2, patients will be given information on interpretation of weekly adherence feedback report. If the patient chooses a family/friend, they will be called and provided information on the interpretation of weekly adherence feedback report. If the patient chooses a reciprocal partner, they will be assigned to another patient who has made a similar choice
Receives: Behavioral: Individual Feedback; Behavioral: Feedback Friend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    Adherence will be measured using the following formula: [Number of times the pill bottle was opened/(Number of times a day each medication is prescribed to be taken multiplied by the total number of days in study)].

    Measured: Change in baseline adherence at 3 month and 6 month

Secondary outcomes (3)

  1. Patient Activation

    The investigators will utilize the 13-item Patient Activation Measure (PAM) to measure an individual's activation level.18 This tool has been used in previous studies to predict self-efficacy for health behaviors, such as exercise and medications adherence. Response categories for each item are strongly agree, agree, disagree and strongly disagree. Responses are then scaled and transformed to a score ranging from 0 to 100. These scores are correlated with four stages of activation.

    Measured: Change in baseline patient activation at 3 month and 6 month

  2. Social Support

    The multidimensional scale of perceived social support will be given at baseline, 3-months, and 6-months. This is a 12-item questionnaire is a validated measure of social support. For each item, respondents must choose one answer that reflects their assessment of social support on a 7-point scale.19 The items divide into 3 main factors of support: Family, Friends, and Significant other.

    Measured: Change in baseline social support at 3 month and 6 month

  3. LDL levels

    The investigators will obtain baseline LDL levels for each patient prior to the intervention. In addition to monitor impact of adherence to the statin medication the investigators will obtain LDL levels at baseline and 6-month time periods for all patients.

    Measured: Change in baseline LDL level at 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startJan 2014
  3. Primary completion3 Sep 2015
  4. Study completion3 Sep 2015

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480530
Sponsor's protocol ID
01461
Status last verified
Jan 2018
First submitted
1 May 2014
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Reddy A, Huseman TL, Canamucio A, Marcus SC, Asch DA, Volpp K, Long JA. Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial. J Gen Intern Med. 2017 Mar;32(3):256-261. doi: 10.1007/s11606-016-3858-0. Epub 2016 Sep 9.

    PubMed 27612487

Questions about this trial

What is this clinical trial studying?

A study testing Individual Feedback and Feedback Friend in people with Coronary Artery Disease and Adherence, run by Corporal Michael J. Crescenz VA Medical Center 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 5 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 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Change in baseline adherence at 3 month and 6 month). 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 NCT02480530, 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 30 Jan 2018.

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