NCT01886170

Brief Summary

In this two-phase mixed methods study, the investigators will first use patient feedback from semi-structured interviews to explore the ways in which patients with diabetes understand their diabetes and assess their disease control. The investigators will also use these interviews to elicit patient feedback on promising alternative communication formats to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new formats to communicate information regarding diabetes control to patients with poorly controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard medical information) versus two alternative formats on several participant outcomes, primarily glycemic control at 6 months post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2013

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

First Submitted

Initial submission to the registry

June 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

June 20, 2013

Last Update Submit

September 21, 2015

Conditions

Diabetes

Keywords

Adults with self-reported diagnosis of diabetes recruited from waiting rooms at outpatient primary care sites at the University of Pennsylvania

Outcome Measures

Primary Outcomes (2)

  • For Phase I of the Study: Metrics Used to Understand Diabetes Control

    Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses

    4 months

  • For Phase II of the Study: Change in Hemoglobin A1C

    Change in A1C between enrollment and 6-months compared between study arms.

    6 months following enrollment

Secondary Outcomes (2)

  • For Phase I of the study: Feedback on alternative formats

    4 months

  • For Phase II of the Study: Understanding of diabetes control

    At the time of enrollment

Study Arms (3)

Hemoglobin A1C

NO INTERVENTION

The arms apply to the second phase of the study. This is the control arm. Participants will receive information regarding their diabetes control using the hemoglobin A1C value (standard medical information)

Experimental Format #1

EXPERIMENTAL

In phase II of the study, participants in this arm will receive information about their current diabetes control conveyed using experimental format #1. The experimental formats will be determined based on the results from Phase I of the study.

Other: Phase II of the Study: Information regarding Current Diabetes Control

Experimental Format #2

EXPERIMENTAL

In phase II of the study, participants in this arm will receive information about their current diabetes control conveyed using experimental format #2. The experimental formats will be determined based on the results from Phase I of the study.

Other: Phase II of the Study: Information regarding Current Diabetes Control

Interventions

Phase II of the Study: Information regarding Current Diabetes ControlOTHER

Participants will receive information regarding their current diabetes control in different ways depending on their assigned study arm.

Experimental Format #1Experimental Format #2

Eligibility Criteria

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

You may qualify if:

  • Adults who report a diagnosis of diabetes

You may not qualify if:

  • People without diabetes
  • For Phase II:
  • Adults seen at University of Pennsylvania primary care practice with a diagnosis of diabetes documented in the electronic health record and a recent hemoglobin A1C \>8 %
  • No diabetes
  • No A1C or recent A1C \<8%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Gopalan A, Suttner L, Troxel AB, McDonough K, Schapira MM. Testing patient-informed approaches for visually depicting the hemoglobin A1c value to patients with poorly controlled diabetes: a randomized, controlled trial. BMC Health Serv Res. 2020 Mar 6;20(1):178. doi: 10.1186/s12913-020-5035-8.

    PMID: 32143649DERIVED

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
Robert Wood Johnson Clinical Scholar

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 25, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(1)