Chronic IllnessCoTSNCT03530709
Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers
A study testing videoconferencing in people with Chronic Illness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- videoconferencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2022
- 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
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers
This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.
- Conditions
- Chronic Illness
- Being tested
- videoconferencing
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoconferencingOther
Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | videoconferencing Receives: Other: videoconferencing |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of co-managed visits scheduled that are completed through videoconferencing
To determine the feasibility of scheduled visits that are completed through videoconferencing
Measured: 12 months
Secondary outcomes (1)
Caregiver Perception of integrated care
Instrument that measures the perception of how well care is integrated. This is a validated, caregiver-reported outcome
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jun 2021
- Primary completion15 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne Van Cleave, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530709
- Sponsor's protocol ID
- 17-1889
- Acronym
- CoTS
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers
- ClinicalTrials.gov ID
- NCT03530709
- Acronym / sponsor ID
- CoTS / 17-1889
- Conditions
- Chronic Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 May 2018 (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.
This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: videoconferencingvideoconferencing |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| videoconferencingParents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits | Other | Experimental |
Primary outcome
Proportion of co-managed visits scheduled that are completed through videoconferencing
Time frame: 12 months
To determine the feasibility of scheduled visits that are completed through videoconferencing
1 secondary outcome
Caregiver Perception of integrated care
Time frame: Baseline, 3 months and 6 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 8 Nov 2023.
- 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.
Jeanne Van Cleave principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videoconferencing in people with Chronic Illness, run by University of Colorado, Denver 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 0 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 8 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?
Proportion of co-managed visits scheduled that are completed through videoconferencing (time frame: 12 months). 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 8 Nov 2023.