Skip to main content
OpenTrials
Completed

NCT Number: NCT04568382

Diabetes Communication and Treatment Burden

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Multiple Chronic Conditions Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CI-PVP (context-informed pre-visit planning)

Other

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

Standard PVP (pre-visit planning)

Other

standard clinic staff chart review, email and/or phone call prior to diabetes office visit

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. Physician Job Satisfaction Scale

    Time frame: change from baseline to 4 months post visit

    validated survey on elements of physician job satisfaction

  12. Maslach Burnout Inventory Human Services Survey for Medical Personnel

    Time frame: change from baseline to 4 months post visit

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Sep 29, 2020
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.