Preventive CareAPPPNCT02915653
Adult Primary and Preventive Practice (APPP) Study
A study testing Educational materials on a new diagnostic service in people with Preventive Care, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
The study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preventive Care
- What is being tested?
- Educational materials on a new diagnostic service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Nov 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. English-speaking 7. Community / non-academic based practice setting 8. ≥ 40 patients under care weekly 9. Access to the internet
Who cannot join
- 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have practiced as a board-certified physician for less than 2 or greater than 30 years 4. Follow <40 patients weekly 5. Non-English speaking 6. Unable to access the internet
Trial locations and contacts
1 site in 1 country.
About this study
The study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms.
- Conditions
- Preventive Care
- Being tested
- Educational materials on a new diagnostic service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materials on a new diagnostic serviceOther
Educational materials on a new diagnostic service
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control: not receiving any intervention |
| Intervention 1 | Experimental | Receiving educational materials on a new diagnostic service Receives: Other: Educational materials on a new diagnostic service |
| Intervention 2 | Experimental | Receiving educational materials on a new diagnostic service Receives: Other: Educational materials on a new diagnostic service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Care
Difference in difference of combined diagnostic and treatment CPV domain scores, including colonoscopy referral rates, in post-intervention versus baseline comparing intervention and control groups among the three patient types.
Measured: 8 weeks
Secondary outcomes (3)
Intervention Impact on Care
Difference in difference between the control and intervention groups in the overall quality of care for CRC screening and for adult primary prevention care measured by the combined and individual item CPV scores for the three patient types.
Measured: 8 weeks
Healthcare Utilization
Difference in health care utilization and/or costs in patients tested with SimpliPro Colon™ versus the control group.
Measured: 8 weeks
Diagnostic Method Comparison
Difference in recommendation of CRC evaluation with colonoscopy and/or flexible sigmoidoscopy, double barium enema, or CT colonography, including risk-level and urgency pre- and post-intervention, between intervention and control groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive CareStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Applied Proteomics Inc
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915653
- Sponsor's protocol ID
- Pro000018813
- Acronym
- APPP
- Status last verified
- Jun 2018
- First submitted
- 22 Sep 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Primary and Preventive Practice (APPP) Study
- ClinicalTrials.gov ID
- NCT02915653
- Acronym / sponsor ID
- APPP / Pro000018813
- Conditions
- Preventive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Applied Proteomics Inc
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Sep 2016 (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 study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control: not receiving any intervention |
| Intervention 1 | Experimental | Other: Educational materials on a new diagnostic serviceReceiving educational materials on a new diagnostic service |
| Intervention 2 | Experimental | Other: Educational materials on a new diagnostic serviceReceiving educational materials on a new diagnostic service |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. English-speaking 7. Community / non-academic based practice setting 8. ≥ 40 patients under care weekly 9. Access to the internet
Key exclusion criteria (1 listed)
- 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have practiced as a board-certified physician for less than 2 or greater than 30 years 4. Follow <40 patients weekly 5. Non-English speaking 6. Unable to access the internet
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 |
|---|---|---|
| Educational materials on a new diagnostic serviceEducational materials on a new diagnostic service | Other | Intervention 1, Intervention 2 |
Primary outcome
Quality of Care
Time frame: 8 weeks
Difference in difference of combined diagnostic and treatment CPV domain scores, including colonoscopy referral rates, in post-intervention versus baseline comparing intervention and control groups among the three patient types.
3 secondary outcomes
Intervention Impact on Care
Time frame: 8 weeks
Healthcare Utilization
Time frame: 8 weeks
Diagnostic Method Comparison
Time frame: 8 weeks
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 20 Jun 2018.
- Individual participant dataSharing planned: No
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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.
John Peabody, MD, PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials on a new diagnostic service in people with Preventive Care, run by Qure Healthcare, LLC 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 1 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 20 Jun 2018. 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?
Quality of Care (time frame: 8 weeks). 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 20 Jun 2018.