DementiaNCT03916588
Dementia Management With Interactive Technology
An observational study of Dementia and Memory Disorders in Old Age, run by Ochsner Health System at 1 site in United States.
Trial summary
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Memory Disorders in Old Age
- What is being tested?
- Individualized Care Plan
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 31 Dec 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative.
Who may be able to join
- Residents living in a specific locked memory care unit in Southeastern Louisiana or
- Family or staff identified as part of the care team of the resident
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.
- Conditions
- Dementia, Memory Disorders in Old Age
- Being tested
- Individualized Care Plan
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Care PlanBehavioural
Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs
| Study group | Role | What they receive |
|---|---|---|
| Memory Care Unit Residents | Residents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident. Receives: Behavioral: Individualized Care Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality/Survival Rate
Measured: through study completion, an average of 1 year
Quality of Life Scale (QoL)
Neuropsychiatric/behavioral symptoms
Measured: through study completion, an average of 1 year
Fall Incidence
Neuropsychiatric/behavioral symptoms
Measured: through study completion, an average of 1 year
Zarit Caregiver Burden
Family burden
Measured: through study completion, an average of 1 year
Patient Care Team Burden Scale (PCTB)
staff caregiver burden
Measured: through study completion, an average of 1 year
Healthcare Utilization
Number of visits to hospital or clinic
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Fitbit Charge HR activity and sleep data
Average daily steps, minutes asleep
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start16 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Dec 2020
Why it stopped: covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R. John Sawyer, PhD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916588
- Sponsor's protocol ID
- 2018.078
- Status last verified
- Sep 2021
- First submitted
- 10 Apr 2019
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Management With Interactive Technology
- ClinicalTrials.gov ID
- NCT03916588
- Acronym / sponsor ID
- 2018.078
- Conditions
- Dementia, Memory Disorders in Old Age
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: covid
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Apr 2019 (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.
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory Care Unit Residents | – | Behavioral: Individualized Care PlanResidents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative.
Key inclusion criteria (2 listed)
- Residents living in a specific locked memory care unit in Southeastern Louisiana or
- Family or staff identified as part of the care team of the resident
Key exclusion criteria (0 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 |
|---|---|---|
| Individualized Care PlanMedical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs | Behavioural | Memory Care Unit Residents |
Primary outcome
Mortality/Survival Rate
Time frame: through study completion, an average of 1 year
Quality of Life Scale (QoL)
Time frame: through study completion, an average of 1 year
Neuropsychiatric/behavioral symptoms
Fall Incidence
Time frame: through study completion, an average of 1 year
Neuropsychiatric/behavioral symptoms
Zarit Caregiver Burden
Time frame: through study completion, an average of 1 year
Family burden
Patient Care Team Burden Scale (PCTB)
Time frame: through study completion, an average of 1 year
staff caregiver burden
Healthcare Utilization
Time frame: through study completion, an average of 1 year
Number of visits to hospital or clinic
1 secondary outcome
Fitbit Charge HR activity and sleep data
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
R. John Sawyer, PhD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Memory Disorders in Old Age, run by Ochsner Health System 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 16 Sep 2021. 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 was stopped early (reason given: covid). Results are not available in the source record.
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?
Mortality/Survival Rate (time frame: through study completion, an average of 1 year). The study lists 6 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 16 Sep 2021.