## Protocol Section
### Identification Module
**NCT ID:** NCT02110979

**Brief Title:** Validation of a Patient Decision Aid for Type 2 Diabetes

**Official Title:** Validation of a Patient Decision Aid for Type 2 Diabetes

#### Organization Study ID Info
**ID:** 70-1036-015
#### Organization
**Class:** OTHER
**Full Name:** EPI-Q
### Status Module
#### Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-08-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-08-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-05

**Type:** ACTUAL

#### Start Date
**Date:** 2014-04

**Status Verified Date:** 2015-08

#### Study First Post Date
**Date:** 2014-04-10
**Type:** ESTIMATED
**Study First Submit Date:** 2014-04-04
**Study First Submit QC Date:** 2014-04-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** EPI-Q

#### Responsible Party

**Investigator Affiliation:** EPI-Q

**Investigator Full Name:** Alicia Shillington

**Investigator Title:** Executive Vice President

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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 Module

**Conditions:**

- Diabetes Mellitus, Type 2

**Keywords:**

- Patient Decision Aid

- Shared Decision Making

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Use of a PDA to assist shared decision making

**Label:** PDA

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive usual care as determined by their clinician.

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PDA

**Name:** Use of a PDA to assist shared decision making

**Other Names:**

- Patient Decision Aid

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The primary endpoint for this investigation is the knowledge total score at final followup 4- 6 weeks after randomization between the PDA versus usual care groups. Questions are about available treatments and specific to the information on medication options available to people with type 2 diabetes when metformin alone does not achieve adequate glycemic control.

**Measure:** Knowledge score

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Measured by using the Decisional Conflict Scale (DCS). Scale will measure domains including: (1) uncertainty in choosing among alternatives; (2) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about values and unsupported in decision making; and (3) perceived quality of decision making. Global decision conflict score and perceived effective decision sub-score will be summarized descriptively following decision and will be compared between arms. Sub-scores are: Uncertainty, Informed, Values clarity, and Support.

**Measure:** Decisional conflict

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Oak Brook

**Country:** United States

**Facility:** EPI-Q Inc

**State:** Illinois

**Zip:** 60523

**Location 2:**

**City:** Oak Brook

**Country:** United States

**Facility:** EPI-Q

**State:** Illinois

**Zip:** 60523

#### Overall Officials

**Official 1:**

**Affiliation:** EPI-Q

**Name:** Alicia Shillington, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.

**PMID:** 26762150

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-24
