DementiaNCT03352791
The Dementia Symptom Management at Home Program Hospice Edition
A study testing DSM-H Hospice Edition performance improvement program in people with Dementia, run by NYU Langone Health at 1 site in United States.
Trial summary
Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- DSM-H Hospice Edition performance improvement program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 5 Oct 2018
- 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
- PWD over the age of 65
- Admitted to MJHS hospice agency
- The patient and family caregiver speak English and/or Spanish.
- The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
- Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).
Who cannot join
- Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
- PWD residing in assisted living facilities, nursing homes or board and care homes
- PWD solely receiving infusion or home health aide services.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition
Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.
- Conditions
- Dementia
- Being tested
- DSM-H Hospice Edition performance improvement program, Usual Care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM-H Hospice Edition performance improvement programBehavioural
Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program
Usual CareBehavioural
control will receive usual care from a care team who has not received the performance improvement program.
| Study group | Role | What they receive |
|---|---|---|
| DSM-H Hospice Edition | Active comparator | training, assigning of champions to serve as mentors and performance improvement leads, and workflow changes including caregiver education pamphlets, interdisciplinary care plans, treatment algorithms, and assessment instruments. Receives: Behavioral: DSM-H Hospice Edition performance improvement program |
| Control Arm | Active comparator | Usual Care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain (PAINAD)
pain assessment tool for use in persons with moderate to severe dementia who cannot provide reliable report, and will be used if the QDRS>12
Measured: Day 0 and Day 30
Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):
13-item tool that measures caregiver perception of BPSD presence and severity in PWD
Measured: Day 0 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Aug 2018
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: Due to operational changes at the participating agency.
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.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham Brody, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352791
- Sponsor's protocol ID
- 17-01080
- Status last verified
- Dec 2019
- First submitted
- 21 Nov 2017
- Last updated
- 4 Dec 2019
- 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition
- ClinicalTrials.gov ID
- NCT03352791
- Acronym / sponsor ID
- 17-01080
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to operational changes at the participating agency.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 24 Nov 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.
Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSM-H Hospice Edition | Active comparator | Behavioral: DSM-H Hospice Edition performance improvement programtraining, assigning of champions to serve as mentors and performance improvement leads, and workflow changes including caregiver education pamphlets, interdisciplinary care plans, treatment algorithms, and assessment instruments. |
| Control Arm | Active comparator | Behavioral: Usual CareUsual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PWD over the age of 65
- Admitted to MJHS hospice agency
- The patient and family caregiver speak English and/or Spanish.
- The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
- Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).
Key exclusion criteria (3 listed)
- Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
- PWD residing in assisted living facilities, nursing homes or board and care homes
- PWD solely receiving infusion or home health aide services.
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 |
|---|---|---|
| DSM-H Hospice Edition performance improvement programPatients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program | Behavioural | DSM-H Hospice Edition |
| Usual Carecontrol will receive usual care from a care team who has not received the performance improvement program. | Behavioural | Control Arm |
Primary outcome
Reduction in pain (PAINAD)
Time frame: Day 0 and Day 30
pain assessment tool for use in persons with moderate to severe dementia who cannot provide reliable report, and will be used if the QDRS>12
Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):
Time frame: Day 0 and Day 30
13-item tool that measures caregiver perception of BPSD presence and severity in PWD
Results and safety
The study was stopped early (reason given: Due to operational changes at the participating agency.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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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.
Abraham Brody, PhD principal investigator
NYU Langone 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 DSM-H Hospice Edition performance improvement program in people with Dementia, run by NYU Langone Health 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 5 inclusion and 3 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 4 Dec 2019. 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: Due to operational changes at the participating agency.). 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?
Reduction in pain (PAINAD) (time frame: Day 0 and Day 30). 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 4 Dec 2019.