Alzheimer's DiseaseNCT05888610
Caregiver Solutions for Dementia Patients
A study testing Digital Outpost in people with Alzheimer's Disease and Dementia, run by Prepped Health LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia, Caregivers
- What is being tested?
- Digital Outpost
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 12 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program
- The ability to speak and understand English
- Age > 18 years
Who cannot join
- Those unable to speak and understand English
- Age ≤ 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Specifications for Caregiver-assisted Solutions to Assess Dementia Patient Needs at Home
The goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?
- Conditions
- Alzheimer's Disease, Dementia, Caregivers, Remote Monitoring
- Being tested
- Digital Outpost
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital OutpostBehavioural
A mobile application that allows caregivers of patients diagnosed with Alzheimer's Disease and Related Dementias to report patient symptom remotely to their clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Digital Outpost | Experimental | Not described Receives: Behavioral: Digital Outpost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days that Participants Use Digital Outpost
Completion of at least 75% of Digital Outpost across 4 days within a 2-week period
Measured: Time Frame up to week 2
Number of Clinical Assessments Completed
Completion of at least 75% of Clinical Assessments
Measured: Time Frame up to week 2
Secondary outcomes (1)
Usability as Measured by the System Usability Scale at 2 weeks
The System Usability Scale will be used for rating technology usability. The measure has 10 items. Each item is measured on a 10-point scale ranging from 0-10. The total score ranges from 0-100, where higher scores indicate greater usability.
Measured: Time Frame 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start12 Jun 2023
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prepped Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888610
- Sponsor's protocol ID
- 00109123
- Status last verified
- Nov 2023
- First submitted
- 10 May 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Specifications for Caregiver-assisted Solutions to Assess Dementia Patient Needs at Home
- ClinicalTrials.gov ID
- NCT05888610
- Acronym / sponsor ID
- 00109123
- Conditions
- Alzheimer's Disease, Dementia, Caregivers, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prepped Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 5 Jun 2023 (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 goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Outpost | Experimental | Behavioral: Digital Outpost |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program
- The ability to speak and understand English
- Age > 18 years
Key exclusion criteria (2 listed)
- Those unable to speak and understand English
- Age ≤ 18 years
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 |
|---|---|---|
| Digital OutpostA mobile application that allows caregivers of patients diagnosed with Alzheimer's Disease and Related Dementias to report patient symptom remotely to their clinical team. | Behavioural | Digital Outpost |
Primary outcome
Number of Days that Participants Use Digital Outpost
Time frame: Time Frame up to week 2
Completion of at least 75% of Digital Outpost across 4 days within a 2-week period
Number of Clinical Assessments Completed
Time frame: Time Frame up to week 2
Completion of at least 75% of Clinical Assessments
1 secondary outcome
Usability as Measured by the System Usability Scale at 2 weeks
Time frame: Time Frame 2 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 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Outpost in people with Alzheimer's Disease and Dementia, run by Prepped Health 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 3 inclusion and 2 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 29 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?
Number of Days that Participants Use Digital Outpost (time frame: Time Frame up to week 2). 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?
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 29 Nov 2023.