Completed

Improving Medication Adherence in Comorbid Conditions

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What is being tested

telephone counseling

Behavioral
Who is being recruted

Diabetes Mellitus, Type 2

+ Hypertension
+ Hyperlipidemia
Over 40 Years

See all eligibility criteria

How is the trial designed

Other Study

Interventional

See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: February 15, 2010
Sourced from a government-validated database.Claim as a partner

This study is designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Individuals need to be 40 years of age or older and on oral medication (pills) management for two of the three conditions of interest. They may also be on other treatment such as insulin, diet and/or exercise programs. Individuals will be followed for approximately 12 months. About 1/4 of the persons in the study will receive a telephone counseling program with a nurse focused upon their management of their treatment program.

Official TitleImproving Medication Adherence in Comorbid Conditions 
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: February 15, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
400 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus, Type 2
Hypertension
Hyperlipidemia
Criteria

* Type 2 diabetes mellitus, hypertension and/or hyperlipidemia, * On oral medication for two of the above conditions, * Manage own medications, * Must have access to a telephone, * Not participating in other adherence education or counseling trials

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Pittsburgh School of NursingPittsburgh, United StatesSee the location
CompletedOne Study Center