Diabetes Mellitus, Type 2NCT04568382
Diabetes Communication and Treatment Burden
A study testing CI-PVP (context-informed pre-visit planning) and Standard PVP (pre-visit planning) in people with Diabetes Mellitus, Type 2 and Multiple Chronic Conditions, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Multiple Chronic Conditions
- What is being tested?
- CI-PVP (context-informed pre-visit planning) and Standard PVP (pre-visit planning)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 30 Jun 2023
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: 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.
- Being tested
- CI-PVP (context-informed pre-visit planning), Standard PVP (pre-visit planning)
- Medical subject headings
- Diabetes Mellitus, Type 2, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Enhanced PVP Receives: Other: CI-PVP (context-informed pre-visit planning) |
| Standard | Active comparator | Standard PVP Receives: Other: Standard PVP (pre-visit planning) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot feasibility
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
Measured: at completion of study, 4 months after last study visit
Pilot acceptability)
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
Measured: after each clinic visit, within 2 weeks; at end of study
Secondary outcomes (14)
Treatment Burden of Diabetes Care Questionnaire (TBQ)
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
Measured: change from baseline to 4 months post visit
Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection
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
Measured: change from baseline to 4 months post visit
Healthcare Climate Questionnaire (HCQ)
a validated survey of patient experience with their healthcare; 6 items on a 7 point Likert scale, 6-42, higher score is better
Measured: change from baseline to 4 months post visit
Patient Self-Activation Measure (PAM-13) short form
a validated measure of patient participation in their own healthcare; 13 items on a 4 point Likert scale, 13-52, higher score is better
Measured: change from baseline to 4 months post visit
Perceived Diabetes Self-Management Scale
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
Measured: change from baseline to 4 months post visit
SF-12, Short Form 12 questions Health Survey
a validated 12 question survey on patient's physical and mental health
Measured: change from baseline to 4 months post visit
Discussion of social determinants of health (SDH) during clinic visit, self-reported
a single question survey, self-reporting by the participant, if SDH were discussed between the doctor and the patient during the visit
Measured: after each clinic visit, within 2 weeks
HgbA1c value
change in A1c level from baseline to post-study, using values nearest to study start and end dates
Measured: change from baseline to 4 months post visit
Blood pressure measurement
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.
Measured: change from baseline to 4 months post visit
Body Mass Index
Body Mass Index change from beginning of study to the end of the study, using most recent height available
Measured: change from baseline to 4 months post visit
Physician Job Satisfaction Scale
validated survey on elements of physician job satisfaction
Measured: change from baseline to 4 months post visit
Maslach Burnout Inventory Human Services Survey for Medical Personnel
Measured: change from baseline to 4 months post visit
Depression symptoms
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
Measured: change from baseline to 4 months post visit
Anxiety Symptoms
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
Measured: change from baseline to 4 months post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start12 Oct 2020
- Primary completion30 Nov 2021
- Study completion30 Jun 2023
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Marianne Magnan, University of California, Davis
- Investigators
- Elizabeth Magnan, MD, Principal investigator, UCDavis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568382
- Sponsor's protocol ID
- 1619593
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.
Publications
Magnan E, Gosdin M, Tancredi D, Jerant A. Pilot randomized controlled trial Protocol: Life context-informed pre-visit planning to improve care plans for primary care patients with multiple chronic conditions including diabetes. J Multimorb Comorb. 2021 Dec 1;11:26335565211062387. doi: 10.1177/26335565211062387. eCollection 2021 Jan-Dec.
PubMed 34881189
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT04568382
- Acronym / sponsor ID
- 1619593
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Sep 2020 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: CI-PVP (context-informed pre-visit planning)Enhanced PVP |
| Standard | Active comparator | Other: Standard PVP (pre-visit planning)Standard PVP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- does not meet inclusion criteria
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 |
|---|---|---|
| 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 | Other | Intervention |
| Standard PVP (pre-visit planning)standard clinic staff chart review, email and/or phone call prior to diabetes office visit | Other | Standard |
Primary outcome
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
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
14 secondary outcomes
Treatment Burden of Diabetes Care Questionnaire (TBQ)
Time frame: 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
Healthcare Climate Questionnaire (HCQ)
Time frame: 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
Perceived Diabetes Self-Management Scale
Time frame: 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
Discussion of social determinants of health (SDH) during clinic visit, self-reported
Time frame: after each clinic visit, within 2 weeks
HgbA1c value
Time frame: change from baseline to 4 months post visit
Blood pressure measurement
Time frame: change from baseline to 4 months post visit
Body Mass Index
Time frame: change from baseline to 4 months post visit
Physician Job Satisfaction Scale
Time frame: 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
Depression symptoms
Time frame: change from baseline to 4 months post visit
Anxiety Symptoms
Time frame: change from baseline to 4 months post visit
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 15 Nov 2023.
- Derived from this study: PubMed 34881189Magnan E, Gosdin M, Tancredi D, Jerant A. Pilot randomized controlled trial Protocol: Life context-informed pre-visit planning to improve care plans for primary care patients with multiple chronic conditions including diabetes. J Multimorb Comorb. 2021 Dec 1;11:26335565211062387. doi: 10.1177/26335565211062387. eCollection 2021 Jan-Dec.
- Individual participant dataSharing planned: No. Plan to share anonymized or de-identified data per IRB approval to researchers at my institution.
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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.
Elizabeth Magnan, MD principal investigator
UCDavis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CI-PVP (context-informed pre-visit planning) and Standard PVP (pre-visit planning) in people with Diabetes Mellitus, Type 2 and Multiple Chronic Conditions, run by University of California, Davis 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 10 inclusion and 1 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 15 Nov 2023. 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?
Pilot feasibility (time frame: at completion of study, 4 months after last study visit). 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 NCT04568382, 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 15 Nov 2023.