Children/Youth With Special Healthcare NeedsNCT05056493
Caremap: A Digital Personal Health Record for Complex Care Coordination
A study testing Caremap app in people with Children/Youth With Special Healthcare Needs and Adults With Multiple Chronic Conditions, run by Duke University at 1 site in United States.
Trial summary
This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Children/Youth With Special Healthcare Needs, Adults With Multiple Chronic Conditions
- What is being tested?
- Caremap app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 29 Mar 2024
- 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
- Non-English speaking
- Living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
- Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account)
- Lack of decision-making capacity (clinician-determined; e.g., patients with advanced dementia)
Trial locations and contacts
1 site in 1 country.
About this study
This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.
- Being tested
- Caremap app
- Keywords
- complex care, mobile health, care coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caremap appOther
The Caremap app is intended for organizing and tracking patient-reported health insights over time and sharing those trends and patient-centered goals with their providers, not for urgent/emergent clinical communication. Information shared with providers through the app will be used for clinical care at the discretion of their provider. Use of the app to share information and health insights will not replace usual, existing channels for patient-provider communication (e.g., MyChart, phone calls, email, pager, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Clinical Providers | Experimental | Clinical provider site champions will be invited to participate in web-based quantitative surveys and a semi-structured interview Receives: Other: Caremap app |
| Parent/Caregivers | Experimental | Patient and parent/caregiver subjects from the participating clinic sites will be enrolled. These participants are all adults - parents or caregivers of children and youth with special health care needs (CYSHCN) and adult patients with multiple chronic conditions (MCC) who are already receiving care at Duke Health. Receives: Other: Caremap app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation feasibility as measured by feasibility intervention measure (FIM)
The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).
Measured: 6 months
Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.
Measured: Weekly, up to 6 months
Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).
Measured: Baseline, 6 months
Change in parent report of their child's health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey
For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.
Measured: Baseline, 3 months, 6 months
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (9)
Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver
App engagement will be defined by number of app log-ins by the parent/patient
Measured: Weekly, up to 6 months
Changes in adoption as measured by quantitative measurement of app engagement by provider
App engagement will be defined by number of views of the clinician dashboard by the provider
Measured: Monthly, up to 6 months
Changes in adoption as measured by quantitative measurement of app prescription by provider
App prescription is the process by which a clinical providers recommends the app to their patient(s) by sending the link for downloading the app, app user overview materials, and study-related materials (including e-informed consent) to the patient directly through the EHR online patient portal. This process is called a "digital prescription" of the app and will be tracked as a marker of app adoption by providers.
Measured: Monthly, up to 6 months
Adaptations made by families and providers during real-world use as measured by survey
Adaptation survey is a 5-item item survey based on the published Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) and is designed to gather patient/parent and providers perspectives on how they have adapted the use and implementation of Caremap in real-world settings.
Measured: Monthly, up to 6 months
Mobile app usability as measured by the System Usability Scale (SUS)
The System Usability Scale is a 10 item survey that gathers user-reported ratings (from parents/patients and providers) of the usability of the Caremap app
Measured: 6 months
Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
The Parent-Patient Activation Measure (P-PAM) is a 13-item parent-reported survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Measured: Baseline, 6 months
Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)
The PAM is a 13-item survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Measured: Baseline, 6 months
Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)
The numeric rating scale is 1 question
Measured: Weekly for 6 months
Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters
Acute encounters include hospital admissions and emergency department visits; and outpatient encounters include primary and specialty clinic visits
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Sep 2022
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children/Youth With Special Healthcare NeedsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- David Y Ming, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056493
- Sponsor's protocol ID
- Pro00108191
- Status last verified
- Nov 2024
- First submitted
- 20 Sep 2021
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caremap: A Digital Personal Health Record for Complex Care Coordination
- ClinicalTrials.gov ID
- NCT05056493
- Acronym / sponsor ID
- Pro00108191
- Keywords
- complex care, mobile health, care coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 24 Sep 2021 (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 study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Providers | Experimental | Other: Caremap appClinical provider site champions will be invited to participate in web-based quantitative surveys and a semi-structured interview |
| Parent/Caregivers | Experimental | Other: Caremap appPatient and parent/caregiver subjects from the participating clinic sites will be enrolled. These participants are all adults - parents or caregivers of children and youth with special health care needs (CYSHCN) and adult patients with multiple chronic conditions (MCC) who are already receiving care at Duke Health. |
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 (4 listed)
- Non-English speaking
- Living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
- Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account)
- Lack of decision-making capacity (clinician-determined; e.g., patients with advanced dementia)
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 |
|---|---|---|
| Caremap appThe Caremap app is intended for organizing and tracking patient-reported health insights over time and sharing those trends and patient-centered goals with their providers, not for urgent/emergent clinical communication. Information shared with providers through the app will be used for clinical care at the discretion of their provider. Use of the app to share information and health insights will not replace usual, existing channels for patient-provider communication (e.g., MyChart, phone calls, email, pager, etc.). | Other | Clinical Providers, Parent/Caregivers |
Primary outcome
Implementation feasibility as measured by feasibility intervention measure (FIM)
Time frame: 6 months
The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).
Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
Time frame: Weekly, up to 6 months
Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.
Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
Time frame: Baseline, 6 months
The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).
Change in parent report of their child's health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey
Time frame: Baseline, 3 months, 6 months
For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
Time frame: Baseline, 3 months, 6 months
For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).
9 secondary outcomes
Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver
Time frame: Weekly, up to 6 months
Changes in adoption as measured by quantitative measurement of app engagement by provider
Time frame: Monthly, up to 6 months
Changes in adoption as measured by quantitative measurement of app prescription by provider
Time frame: Monthly, up to 6 months
Adaptations made by families and providers during real-world use as measured by survey
Time frame: Monthly, up to 6 months
Mobile app usability as measured by the System Usability Scale (SUS)
Time frame: 6 months
Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
Time frame: Baseline, 6 months
Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)
Time frame: Baseline, 6 months
Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)
Time frame: Weekly for 6 months
Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters
Time frame: Baseline, 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 21 Nov 2024.
- Individual participant dataSharing planned: No
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Patient Navigation
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.
David Y Ming, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caremap app in people with Children/Youth With Special Healthcare Needs and Adults With Multiple Chronic Conditions, 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 0 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 21 Nov 2024. 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?
Implementation feasibility as measured by feasibility intervention measure (FIM) (time frame: 6 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 21 Nov 2024.