Validation of a Patient Decision Aid for Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care

NCT00668590

Diabetes

COMPLETED NA

Electronic Decision Support for Intervention in Poorly Controlled Type 2 Diabetes

NCT02924207

Diabetes Mellitus

COMPLETED NA

Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes

NCT02379078

Diabetes Mellitus

COMPLETED NA

A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes

NCT03855449

Diabetes Mellitus, Type 2

COMPLETED NA

Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes

NCT03084900

Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PDA

Subjects receive an internet-based patient decision aid video. The PDA is viewed outside of the doctor's office via a personal computer in preparation for regularly scheduled face to face interaction between patients and clinicians.

Group Type EXPERIMENTAL

Use of a PDA to assist shared decision making

Intervention Type BEHAVIORAL

Usual care

Patients receive usual care as determined by their clinician.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Use of a PDA to assist shared decision making

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patient Decision Aid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Type 2 diabetes
2. Age 18 or older
3. English speaking
4. Currently taking metformin
5. Inadequate glycemic control in the opinion of the investigator
6. Is considering additional medication options on the advice of their physician
7. Can provide a valid email address
8. Access to the internet and able to read and respond to internet questionnaires

Exclusion Criteria

1. Participation in a clinical trial of a diabetes medication within 1 year
2. Currently taking more than two (2) medications for diabetes
3. Has been exposed to diabetes medications from more than three (3) drug classes
4. Adults unable to consent
5. Individuals who are not yet adults (infants, children, teenagers)
6. Pregnant women
7. Prisoners

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No