Type II DiabetesNCT02471794
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study
A study testing Personalized Health Planning Shared Medical Appointment in people with Type II Diabetes, run by Duke University at 1 site in United States.
Trial summary
The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Personalized Health Planning Shared Medical Appointment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- 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
- A diagnosis of Type 2 diabetes within the last year
- A current patient at Duke Family Medicine.
- An A1C score greater than 7 and less than 14.
Who cannot join
- A diagnosis of Pre-diabetes
- A diagnosis of Type I diabetes
- Individuals with amputations as a result of their diabetes are excluded form this study.
- Individuals with renal dialysis will not be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Family Medicine Center
Durham, North Carolina, 27705
About this study
Official title: Personalized Health Planning in Shared Medical Appointments for Individuals With Type II
The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.
Read the detailed description
All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).
- Conditions
- Type II Diabetes
- Being tested
- Personalized Health Planning Shared Medical Appointment
- Keywords
- Type II Diabetes, Personalized Health Planning, Shared Medical Appointments
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Health Planning Shared Medical AppointmentBehavioural
The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum
| Study group | Role | What they receive |
|---|---|---|
| Standard Shared Medical Appointment | No intervention | The SMA group will be a standard shared diabetes medical appointment group consisting of up to 10 patients that utilizes the design and curriculum of the SMAs that are currently being held at the Duke Family Medicine Center. |
| Personalized Health Planning Shared Medical Appointment | Experimental | The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum. Receives: Behavioral: Personalized Health Planning Shared Medical Appointment |
| Retrospective | No intervention | A retrospective chart review will be conducted once all participants (both SMA group and PHP SMA group) complete the intervention. The retrospective chart review will collect healthcare utilization data six months prior, during, and after each subject's participation in the SMA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured using a patient satisfaction survey
Measured: 12 months
Change in patient activation measured using the patient activation measure
Measured: baseline; 6 months; 12 months
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale
Measured: baseline; 6 months; 12 months
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale
Measured: baseline; 6 months; 12 months
Change in A1C using the A1C blood test
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Secondary outcomes (7)
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)
Measured: baseline; 6 months; 12 months
Change in functional health and well-being using the short form health survey
Measured: baseline; 6 months; 12 months
Change in general self-rated health using the general self rated health survey (GSRH)
Measured: baseline; 6 months; 12 months
Change in health goal progress using a goal progress visual analog scale
Measured: 3 months; 10 months
change in body mass index using weight and height measurements
Measured: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
change in blood pressure using blood pressure measurement
Measured: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement
Measured: baseline; 6 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Hull, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471794
- Sponsor's protocol ID
- Pro00063493
- Status last verified
- Jan 2017
- First submitted
- 11 Jun 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Health Planning in Shared Medical Appointments for Individuals With Type II
- ClinicalTrials.gov ID
- NCT02471794
- Acronym / sponsor ID
- Pro00063493
- Conditions
- Type II Diabetes
- Keywords
- Type II Diabetes, Personalized Health Planning, Shared Medical Appointments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jun 2015 (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.
The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.
Detailed description
All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Shared Medical Appointment | No intervention | –The SMA group will be a standard shared diabetes medical appointment group consisting of up to 10 patients that utilizes the design and curriculum of the SMAs that are currently being held at the Duke Family Medicine Center. |
| Personalized Health Planning Shared Medical Appointment | Experimental | Behavioral: Personalized Health Planning Shared Medical AppointmentThe PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum. |
| Retrospective | No intervention | –A retrospective chart review will be conducted once all participants (both SMA group and PHP SMA group) complete the intervention. The retrospective chart review will collect healthcare utilization data six months prior, during, and after each subject's participation in the SMA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of Type 2 diabetes within the last year
- A current patient at Duke Family Medicine.
- An A1C score greater than 7 and less than 14.
Key exclusion criteria (4 listed)
- A diagnosis of Pre-diabetes
- A diagnosis of Type I diabetes
- Individuals with amputations as a result of their diabetes are excluded form this study.
- Individuals with renal dialysis will not be included in this study.
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 |
|---|---|---|
| Personalized Health Planning Shared Medical AppointmentThe PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum | Behavioural | Personalized Health Planning Shared Medical Appointment |
Primary outcome
Feasibility measured using a patient satisfaction survey
Time frame: 12 months
Change in patient activation measured using the patient activation measure
Time frame: baseline; 6 months; 12 months
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale
Time frame: baseline; 6 months; 12 months
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale
Time frame: baseline; 6 months; 12 months
Change in A1C using the A1C blood test
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
7 secondary outcomes
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)
Time frame: baseline; 6 months; 12 months
Change in functional health and well-being using the short form health survey
Time frame: baseline; 6 months; 12 months
Change in general self-rated health using the general self rated health survey (GSRH)
Time frame: baseline; 6 months; 12 months
Change in health goal progress using a goal progress visual analog scale
Time frame: 3 months; 10 months
change in body mass index using weight and height measurements
Time frame: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
change in blood pressure using blood pressure measurement
Time frame: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement
Time frame: baseline; 6 months; 12 months
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 24 Jan 2017.
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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.
Sharon Hull, MD MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Health Planning Shared Medical Appointment in people with Type II Diabetes, run by Duke University 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 3 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 24 Jan 2017. 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?
Feasibility measured using a patient satisfaction survey (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.