DiabetesNCT01886170
Using Patient Feedback to Improve Communication Regarding Glycemic Control to Patients With Diabetes
A study of Diabetes, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who report a diagnosis of diabetes
- -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 %
Who cannot join
- People without diabetes
- For Phase II:
- No diabetes
- No A1C or recent A1C <8%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes
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.
Read the detailed description
The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.
- Conditions
- Diabetes
- Being tested
- Phase II of the Study: Information regarding Current Diabetes Control
- Keywords
- Adults with self-reported diagnosis of diabetes recruited from waiting rooms at outpatient primary care sites at the University of Pennsylvania
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Phase II of the Study: Information regarding Current Diabetes Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
For Phase II of the Study: Change in Hemoglobin A1C
Change in A1C between enrollment and 6-months compared between study arms.
Measured: 6 months following enrollment
Secondary outcomes (2)
For Phase I of the study: Feedback on alternative formats
qualitative and quantitative analysis of the feedback received on the alternative communication formats reviewed with participants during the interviews.
Measured: 4 months
For Phase II of the Study: Understanding of diabetes control
Accuracy of participant knowledge of level of current diabetes control
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anjali Gopalan, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886170
- Sponsor's protocol ID
- 817693
- Other IDs
- 00000notapplicable
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32143649
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes
- ClinicalTrials.gov ID
- NCT01886170
- Acronym / sponsor ID
- 817693
- Conditions
- Diabetes
- Keywords
- Adults with self-reported diagnosis of diabetes recruited from waiting rooms at outpatient primary care sites at the University of Pennsylvania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Phase II of the Study: Information regarding Current Diabetes ControlIn 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. |
| Experimental Format #2 | Experimental | Other: Phase II of the Study: Information regarding Current Diabetes ControlIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults who report a diagnosis of diabetes
- -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 %
Key exclusion criteria (4 listed)
- People without diabetes
- No diabetes
- No A1C or recent A1C <8%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase II of the Study: Information regarding Current Diabetes ControlParticipants will receive information regarding their current diabetes control in different ways depending on their assigned study arm. | Other | Experimental Format #1, Experimental Format #2 |
Primary outcome
For Phase I of the Study: Metrics Used to Understand Diabetes Control
Time frame: 4 months
Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses
For Phase II of the Study: Change in Hemoglobin A1C
Time frame: 6 months following enrollment
Change in A1C between enrollment and 6-months compared between study arms.
2 secondary outcomes
For Phase I of the study: Feedback on alternative formats
Time frame: 4 months
For Phase II of the Study: Understanding of diabetes control
Time frame: At the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 32143649Gopalan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For Phase I of the Study: Metrics Used to Understand Diabetes Control (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.