Diabetes Communication and Treatment Burden

November 14, 2023 updated by: Elizabeth Marianne Magnan, University of California, Davis

The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions

The objective of this proposal is to pilot test two types of pre-visit planning, where clinical staff reviews charts and talks to patients before their doctors appointments, to reduce the burden of diabetes care on the patient without increasing the visit workload during busy primary care clinics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients:

  • patient at the UCD ACC family medicine residency clinic
  • age 18+,
  • has diabetes per Diabetes Registry (HealthyPlanet2020)
  • PLUS at least one other chronic condition
  • attends a primary care office visit (in-person or telehealth) during the study initial data collection period with a physician who is participating in the study
  • speaks and writes English well enough to complete a written or oral survey
  • consents to participate

PCPs:

-sees patients as a primary care physician at the study clinic site

Exclusion Criteria:

  • does not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Enhanced PVP
Other: CI-PVP (context-informed pre-visit planning)
may experience a single additional phone call from clinic staff in addition to the standard clinic staff chart review, email and/or phone call prior to diabetes office visit
Active Comparator: Standard
Standard PVP
Other: Standard PVP (pre-visit planning)
standard clinic staff chart review, email and/or phone call prior to diabetes office visit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pilot feasibility
Time Frame: at completion of study, 4 months after last study visit
patients reached by phone for PVP call after assigned to call; # patients recruited successfully who were eligible; # questions completed on the surveys; # calls made to each patient and to patients total per # patients reached and # patients enrolled; # patients who completed all surveys; qualitative interviews will discuss challenges, barriers, and other feasability concerns to scaling this pilot trial to a definitive multi-center trial
at completion of study, 4 months after last study visit
Pilot acceptability)
Time Frame: after each clinic visit, within 2 weeks; at end of study
a short survey measuring PCPs perception of the visit's difficulty, hassle and effort; qualittive interviews with patients, providers and those conducting the intervention PVP calls
after each clinic visit, within 2 weeks; at end of study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Burden of Diabetes Care Questionnaire (TBQ)
Time Frame: change from baseline to 4 months post visit
a validated survey that measures patient self-assessment of chronic disease care burden; 13 items on a 5 point Likert scale, 13-65, higher score is worse
change from baseline to 4 months post visit
Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection
Time Frame: change from baseline to 4 months post visit
a validated survey that measures patient's self-assessed ability to handle financial aspects of chronic disease care; 5 items on a 5 point Likert scale, 5-25, higher score is worse
change from baseline to 4 months post visit
Healthcare Climate Questionnaire (HCQ)
Time Frame: change from baseline to 4 months post visit
a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better
change from baseline to 4 months post visit
Patient Self-Activation Measure (PAM-13) short form
Time Frame: change from baseline to 4 months post visit
a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better
change from baseline to 4 months post visit
Perceived Diabetes Self-Management Scale
Time Frame: change from baseline to 4 months post visit
a validated survey on the patients perception of their ability to care for their diabetes; 8 items on a 5 point Likert scale, 8-40 higher score is worse
change from baseline to 4 months post visit
SF-12, Short Form 12 questions Health Survey
Time Frame: change from baseline to 4 months post visit
a validated 12 question survey on patient's physical and mental health
change from baseline to 4 months post visit
Discussion of social determinants of health (SDH) during clinic visit, self-reported
Time Frame: after each clinic visit, within 2 weeks
a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit
after each clinic visit, within 2 weeks
HgbA1c value
Time Frame: change from baseline to 4 months post visit
change in A1c level from baseline to post-study, using values nearest to study start and end dates
change from baseline to 4 months post visit
Blood pressure measurement
Time Frame: change from baseline to 4 months post visit
systolic and diastolic blood pressure value pre and psot study, using measures closest to study start and end date, and area-under-the-curve for blood pressure in between.
change from baseline to 4 months post visit
Body Mass Index
Time Frame: change from baseline to 4 months post visit
Body Mass Index change from beginning of study to the end of the study, using most recent height available
change from baseline to 4 months post visit
Physician Job Satisfaction Scale
Time Frame: change from baseline to 4 months post visit
validated survey on elements of physician job satisfaction
change from baseline to 4 months post visit
Maslach Burnout Inventory Human Services Survey for Medical Personnel
Time Frame: change from baseline to 4 months post visit
change from baseline to 4 months post visit
Depression symptoms
Time Frame: change from baseline to 4 months post visit
change in symptom score, as measured by PHQ2 (0-6, higher is worse) or PHQ9 (0-27, higher is worse), as available, done within one month of study start and after visit by study end
change from baseline to 4 months post visit
Anxiety Symptoms
Time Frame: change from baseline to 4 months post visit
change in symptom score, as measured by GAD2 (0-6, higher is worse) or GAD7 (0-21, higher is worse), as available, done within one month of study start and after visit by study end
change from baseline to 4 months post visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Magnan, MD, UCDavis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1619593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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