Dementia AlzheimersTeleNHNCT03378245
Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations
A study testing Behavioral modification and education on pharmacologic treatments. in people with Dementia Alzheimers and Disruptive Behavior, run by Richard Ronan Murphy at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia Alzheimers, Disruptive Behavior
- What is being tested?
- Behavioral modification and education on pharmacologic treatments.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Jul 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dementia Care facility resident Problematic behavioral problems
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations and Healthcare Costs in Appalachia KY Skilled Nursing Facilities
The purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The multidisciplinary team is comprised of trained behavioral neurologists, social workers, advanced practice providers, primary medical team and nurse coordinators.
- Conditions
- Dementia Alzheimers, Disruptive Behavior
- Being tested
- Behavioral modification and education on pharmacologic treatments.
- Medical subject headings
- Alzheimer Disease, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral modification and education on pharmacologic treatments.Behavioural
Education and counseling of care-giving staff on behavioral modification strategies, as well as education about current standard of care best practices for pharmacologic interventions.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Intervention | Experimental | Multidisciplinary telemedicine education of staff and providers on best practices for behavioral modification as well as education on best practices for pharmacologic therapies. Receives: Behavioral: Behavioral modification and education on pharmacologic treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Neuropsychiatric Inventory (NPI) total score
The NPI assesses 10 behavioral symptom domains, scoring is based on symptom frequency and severity. The total NPI score sums the products of frequency and severity scores for each domain. Higher scores indicate more behavioral disturbance
Measured: 6 months
Secondary outcomes (2)
Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
The RUD-FOCA records the care time in three areas: activities of daily living (ADL), instrumental activities of daily living (IADL) and supervision.
Measured: 6 months
Change in Quality of Life in Alzheimers Dementia (QoL-AD)
13 quality of life items are rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52. It generally takes caregivers about 5 minutes to complete the measure.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startSep 2013
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies 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
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Ronan Murphy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Ronan Murphy, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378245
- Sponsor's protocol ID
- 13-0664-P3H
- Acronym
- TeleNH
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2017
- Last updated
- 16 Aug 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations and Healthcare Costs in Appalachia KY Skilled Nursing Facilities
- ClinicalTrials.gov ID
- NCT03378245
- Acronym / sponsor ID
- TeleNH / 13-0664-P3H
- Conditions
- Dementia Alzheimers, Disruptive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Richard Ronan MurphyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 19 Dec 2017 (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 purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The multidisciplinary team is comprised of trained behavioral neurologists, social workers, advanced practice providers, primary medical team and nurse coordinators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Intervention | Experimental | Behavioral: Behavioral modification and education on pharmacologic treatments.Multidisciplinary telemedicine education of staff and providers on best practices for behavioral modification as well as education on best practices for pharmacologic therapies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Dementia Care facility resident Problematic behavioral problems
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Behavioral modification and education on pharmacologic treatments.Education and counseling of care-giving staff on behavioral modification strategies, as well as education about current standard of care best practices for pharmacologic interventions. | Behavioural | Telemedicine Intervention |
Primary outcome
Change in the Neuropsychiatric Inventory (NPI) total score
Time frame: 6 months
The NPI assesses 10 behavioral symptom domains, scoring is based on symptom frequency and severity. The total NPI score sums the products of frequency and severity scores for each domain. Higher scores indicate more behavioral disturbance
2 secondary outcomes
Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
Time frame: 6 months
Change in Quality of Life in Alzheimers Dementia (QoL-AD)
Time frame: 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 16 Aug 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.
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 Behavioral modification and education on pharmacologic treatments. in people with Dementia Alzheimers and Disruptive Behavior, run by Richard Ronan Murphy 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 16 Aug 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 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?
Change in the Neuropsychiatric Inventory (NPI) total score (time frame: 6 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 16 Aug 2021.