DementiaDSM-HNCT02482623
The Dementia Symptom Management at Home Program
A study testing Dementia Symptom Management at Home Program in people with Dementia, run by New York University at 2 sites in United States.
Trial summary
Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia Symptom Management at Home Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 1 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient-caregiver dyad admitted to the HHC agency
- Patients must be 65 or older and speak English and/or Spanish.
- Patient must have an informal caregiver who is at least 18 years old and spends at least 8 hours per week with the patient.
- Patients must score greater than 4 on the cognitive subscale of the Healthy Aging Brain Care Monitor signifying at least mild impairment
Who cannot join
- Patients with concomitant axis I disorders other than dementia, depression, adjustment disorders, sleep disorders.
- Patients being seen only in the behavioral health unit without another skilled need.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The New Jewish Home
New York, New York, 10001
New York University College of Nursing
New York, New York, 10010
About this study
Official title: The Dementia Symptom Management at Home Program: A Bundled Interprofessional Intervention to Improve Dementia Patient-Caregiver Dyad Quality of Care and Quality of Life Through Home Healthcare.
Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.
Read the detailed description
The Dementia Symptom Management at Home (DSM-H) Program is an integrated bundled implementation science intervention to improve interprofessional care in home healthcare (HHC). It consists of training, assessment instruments, patient-caregiver centered care plans and workflow changes. The investigators will perform a cluster randomized controlled clinical trial at a single, urban, non-profit HHC agency, randomizing care teams to either be trained in performing the intervention or serve as controls. The aims of this program are to examine the efficacy of this program to:
Aim 1: Measure the effects of DSM-H on pain, neuropsychiatric symptoms, and caregiver rated QOL in the person with dementia receiving HHC.
Aim 2: Assess the effects of DSM-H on QOL, burden and depression for the informal caregiver of persons with dementia receiving HHC.
Aim 3: Assess the effects of DSM-H on the number of emergency room visits and hospital admissions.
- Conditions
- Dementia
- Being tested
- Dementia Symptom Management at Home Program
- Keywords
- Dementia, neuropsychiatric symptoms, implementation science, depression, pain
- Medical subject headings
- Dementia, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Symptom Management at Home ProgramBehavioural
Also called DSM-H
The DSM-H is a multi-modal interprofessional intervention that includes: 1. intensive training of clinician mentors; 2. disseminated online training for Registered Nurses, Physical Therapists, Occupational Therapists; 3. implementation of evidence-based care plans, assessment instruments, and teaching handouts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dyads in this arm will receive care provided by an interprofessional team trained through the DSM-H to provide patient/caregiver-centered dementia care through home healthcare. Receives: Behavioral: Dementia Symptom Management at Home Program |
| Control | No intervention | Dyads in this arm will receive usual care provided in the home healthcare setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person With Dementia Quality of Life
Quality of Life in Alzheimer's Disease survey instrument
Measured: 60 Days
Caregiver Quality of Life
Caregiver Targeted Quality of Life survey instrument
Measured: 60 Days
Secondary outcomes (6)
Person with Dementia Pain
Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument
Measured: 60 days
Person with Dementia Neuropsychiatric Symptom Burden
Healthy Aging Brain Care Monitor survey instrument
Measured: 60 days
Caregiver Depression
Public Health Questionnaire-9 survey instrument
Measured: 60 days
Person with Dementia ER Visits
Resource Utilization Inventory survey instrument
Measured: 30, 60 days
Person with Dementia Hospital Admissions
Resource Utilization Inventory survey instrument
Measured: 30, 60 days
Person with Dementia Functional Status
Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start1 Aug 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: Loss of study site
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Visiting Nurse Service of New York
- Responsible party
- Sponsor
- Investigators
- Abraham A Brody, RN, PhD, GNP-BC, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482623
- Sponsor's protocol ID
- i14-01960
- Acronym
- DSM-H
- Status last verified
- Sep 2018
- First submitted
- 23 Jun 2015
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dementia Symptom Management at Home Program: A Bundled Interprofessional Intervention to Improve Dementia Patient-Caregiver Dyad Quality of Care and Quality of Life Through Home Healthcare.
- ClinicalTrials.gov ID
- NCT02482623
- Acronym / sponsor ID
- DSM-H / i14-01960
- Conditions
- Dementia
- Keywords
- Dementia, neuropsychiatric symptoms, implementation science, depression, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of study site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Visiting Nurse Service of New York
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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.
Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.
Detailed description
The Dementia Symptom Management at Home (DSM-H) Program is an integrated bundled implementation science intervention to improve interprofessional care in home healthcare (HHC). It consists of training, assessment instruments, patient-caregiver centered care plans and workflow changes. The investigators will perform a cluster randomized controlled clinical trial at a single, urban, non-profit HHC agency, randomizing care teams to either be trained in performing the intervention or serve as controls. The aims of this program are to examine the efficacy of this program to:
Aim 1: Measure the effects of DSM-H on pain, neuropsychiatric symptoms, and caregiver rated QOL in the person with dementia receiving HHC.
Aim 2: Assess the effects of DSM-H on QOL, burden and depression for the informal caregiver of persons with dementia receiving HHC.
Aim 3: Assess the effects of DSM-H on the number of emergency room visits and hospital admissions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dementia Symptom Management at Home ProgramDyads in this arm will receive care provided by an interprofessional team trained through the DSM-H to provide patient/caregiver-centered dementia care through home healthcare. |
| Control | No intervention | –Dyads in this arm will receive usual care provided in the home healthcare setting. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patient-caregiver dyad admitted to the HHC agency
- Patients must be 65 or older and speak English and/or Spanish.
- Patient must have an informal caregiver who is at least 18 years old and spends at least 8 hours per week with the patient.
- Patients must score greater than 4 on the cognitive subscale of the Healthy Aging Brain Care Monitor signifying at least mild impairment
Key exclusion criteria (2 listed)
- Patients with concomitant axis I disorders other than dementia, depression, adjustment disorders, sleep disorders.
- Patients being seen only in the behavioral health unit without another skilled need.
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 |
|---|---|---|
| Dementia Symptom Management at Home ProgramAlso: DSM-HThe DSM-H is a multi-modal interprofessional intervention that includes: 1. intensive training of clinician mentors; 2. disseminated online training for Registered Nurses, Physical Therapists, Occupational Therapists; 3. implementation of evidence-based care plans, assessment instruments, and teaching handouts. | Behavioural | Intervention |
Primary outcome
Person With Dementia Quality of Life
Time frame: 60 Days
Quality of Life in Alzheimer's Disease survey instrument
Caregiver Quality of Life
Time frame: 60 Days
Caregiver Targeted Quality of Life survey instrument
6 secondary outcomes
Person with Dementia Pain
Time frame: 60 days
Person with Dementia Neuropsychiatric Symptom Burden
Time frame: 60 days
Caregiver Depression
Time frame: 60 days
Person with Dementia ER Visits
Time frame: 30, 60 days
Person with Dementia Hospital Admissions
Time frame: 30, 60 days
Person with Dementia Functional Status
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for Dementia
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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 A Brody, RN, PhD, GNP-BC principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Symptom Management at Home Program in people with Dementia, run by New York University at 2 sites 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 4 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: withdrawn, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Person With Dementia Quality of Life (time frame: 60 Days). 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 2 Nov 2022.