Improving Medication Adherence in Older African Americans With Diabetes

August 6, 2020 updated by: Thomas Jefferson University
This research aims to help older African Americans with diabetes and mild memory problems improve how they take their medications and control their diabetes. This may preserve their independence and health, prevent cognitive and functional decline, and reduce health care costs. As the population ages and becomes more racially diverse, finding ways to achieve these outcomes has great public health importance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prevalence of type 2 diabetes (DM) in older persons is increasing rapidly. DM increases the risk for Mild Cognitive Impairment (MCI), which is a transition state between normal cognition and dementia that is often characterized by memory and executive function deficits. These deficits reduce adherence to DM medications, which worsens glycemic control and increases the risk for adverse DM-related health outcomes. Improving medication adherence may prevent these outcomes and reduce health care costs. This is important to all older persons with DM but particularly to older African Americans (AAs). They have twice the rate of DM, worse cognitive function, lower medication adherence, and worse glycemic control than whites. One million older AAs now have DM and their number will double by 2030. Because 30% also have MCI, low medication adherence is an important problem for them. This necessitates culturally relevant interventions that compensate for their cognitive deficits and improves their medication adherence and glycemic control. We propose a randomized controlled clinical trial to test the efficacy of a collaborative Primary Care-Occupational Therapy (PC-OT) intervention to lower hemoglobin A1c (HbA1c) levels in older AAs with DM, MCI, HbA1c ≥ 7.5%, and ≤ 80% adherence to an oral hypoglycemic medication. PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet). We will recruit 100 participants from primary care clinics and randomize them to PC-OT or Enhanced Usual Care (EUC). EUC is usual medical care plus low intensity DM education delivered by community health workers. Participants in both PC-OT and EUC will have 6 initial in-home treatment sessions over 3 months, and then 3 booster sessions during this 12 month study. The primary outcome is a reduction in HbA1c of 0.5%, which reduces the risk of adverse medical events. The primary efficacy analysis compares the proportion of participants in PC-OT and EUC who achieve this outcome at month 6 (short term effect) and at month 12 (maintenance effect). We will measure medication adherence using an electronic Medication Event Monitoring System, prescription refills, and self-reports. A secondary aim determines if improving medication adherence mediates PC-OT's impact on HbA1c levels. We will also evaluate PC-OT's effect on other DSM practices; ER visits and hospitalizations; cognition; function; mood; and quality of life; and PC-OT's costs and net financial benefits. This is the first study to determine if PCPs, collaborating with OTs (who are experts in developing strategies to compensate for cognitive/physical deficits), can improve medication adherence and glycemic control, and prevent cognitive and functional decline in older persons with DM and MCI. If PC-OT is effective in a high risk population of older AAs, its benefits may extend to all older persons with DM and have enormous public health significance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 60 years and older.
  2. Self-identified as African American, black, black American, or black/Caribbean.
  3. Type II DM (i.e., physician diagnosis and medication treatment).
  4. HbA1c level ≥ 7.5%.
  5. MCI, based on National Institute on Aging/Alzheimer's Association (NIA/AA) criteria.
  6. ≤ 80% adherence to an oral hypoglycemic medication or insuling, as documented during a run-in phase using a Medication Event Monitoring System (MEMS).

Exclusion Criteria:

  1. Dementia, based on National Institute on Aging/Alzheimer's Association criteria.
  2. DSM-V psychiatric disorder other than depressive disorders.
  3. End-stage renal disease requiring dialysis.
  4. Hearing/Vision (i.e., severe diabetic retinopathy) or motor (e.g., peripheral neuropathy) impairment that precludes research participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Primary Care-Occupational Therapy
PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
Behavioral: Primary Care-Occupational Therapy
PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
PLACEBO_COMPARATOR: Enhanced Usual Care
Usual care enhanced with education and controls for attention
Behavioral: Enhanced Usual Care
Usual care enhanced with education and attention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of Participants With Improvement in Hemoglobin A1c by 0.5%"
Time Frame: 6 months
Percent of participants who had a reduction (improvement) of at least .5% in hemoglobin A1c from baseline to 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence as Measured By Percentage of Doses Taken as Prescribed
Time Frame: 4-6 months
This was assessed objectively using a Medication Event Monitoring System (MEMS) bottle. The MEMS measured daily bottle openings continuously to assess adherence to insulin or an oral hypoglycemic agent. The adherence rate is the percent of doses that were taken as prescribed.
4-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barry W Rovner, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK102609-01 (NIH)

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