NCT02373059

Brief Summary

A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

February 16, 2015

Last Update Submit

May 6, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Patient Involvement Questionnaire

    Post-Visit up to 2 weeks

Secondary Outcomes (2)

  • Patient Knowledge regarding Diabetes treatments Questionnaire

    post visit up to 2 weeks

  • Patient Medication Adherence Questionnaire

    1 month post visit

Study Arms (2)

Pharmaceutical care with shared decision making

EXPERIMENTAL

Use of Diabetes Issue Cards Decision Aids

Other: Diabetes Issue Cards Decision Aids

Usual Pharmaceutical care

ACTIVE COMPARATOR

Usual Care

Other: Usual Pharmaceutical Care

Interventions

Diabetes Issue Cards Decision AidsOTHER
Pharmaceutical care with shared decision making
Usual Pharmaceutical CareOTHER
Usual Pharmaceutical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age
  • Diagnosed with type II diabetes by ICD-9 code for more than one year
  • HbA1c of 7%-9.5% within past 6 months
  • Prescribed three or less anti-hyperglycemic medications as indicated by the medication list within the medical record

You may not qualify if:

  • Prescribed insulin
  • Pregnancy
  • Appointment with provider within a month
  • Appointment with provider within the last month
  • Followed by endocrinology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Kasson

Kasson, Minnesota, 55944, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Pharmacy

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations

US(1)