Depressive SymptomsNHiCENCT02092987
Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
A study testing Social work support, Educational material and NYU caregiver counseling intervention in people with Depressive Symptoms and Burden, run by Columbia University at 1 site in United States.
Trial summary
The primary research question is which of the 2 best known dementia caregiver interventions, the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden among… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Burden
- What is being tested?
- Social work support, Educational material and NYU caregiver counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self identified Hispanic
- Between the ages of 18 and 90.
- Caregiver is related to persons receiving care either as a spouse (including common law partners) or a blood or in-law relative.
- Person receiving care has been diagnosed with dementia and reports at least 1 memory/cognition and 1 daily functioning symptom in our screening questionnaire (see appendix).
- Caregiver is physically able to provide care
- Caregiver does not have a diagnosis of major psychiatric disorder other than depression.
Show all 9Show fewer
- Caregiver does not have depression with psychotic features or suicidal ideation or attempts in the last 5 years.
- Caregiver is expected to live in New York City in the next 6 months or is available for study procedures in the New York City area.
- There is at least one relative or close friend living in the New York City Metropolitan Area (New York, New Jersey, Connecticut).
Who cannot join
- Not Hispanic
- Caregiver is not a relative as defined in the inclusion criteria.
- Person receiving care does not have dementia
- Other than depression, caregiver has a major psychiatric disorder such as schizophrenia
- Caregiver has depression with psychotic features or suicidal ideation in the last 5 years.
- Severe depression defined by a Patient Health Questionnaire (PHQ)-9 > 20.
- Previous or current participation in caregiver support programs with the NYUCI or the REACH OUT
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The primary research question is which of the 2 best known dementia caregiver interventions, the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden among Hispanic caregivers in New York City. The investigators hypothesize that the NYUCI will be more effective than REACH OUT in reducing caregiver depressive symptoms and burden among Hispanics because of its focus on family-centered counseling, which is posited to be more important among Hispanic caregivers because of a cultural emphasis among Hispanics on family interactions in interventions. In order to answer the primary question, the investigators will conduct a pragmatic randomized trial comparing the NYUCI vs. REACH OUT in 200 Hispanic caregivers of persons with dementia in the community of Northern Manhattan. The total time of the intervention will be 6 months.
Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic relative (any relative) caregivers of persons with dementia. Our objective is to obtain effectiveness information that will help caregivers and health providers to make decisions about which intervention to choose. Our primary aim is to compare the effectiveness of the implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and REACH OUT and to examine additional outcomes such as caregiver stress and physical health, and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic randomized trial of 200 relative caregivers of persons with dementia. Participants will be randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6 months, with assessments at baseline and follow-up. All interventions and questionnaires will be conducted in both English and Spanish. The study duration will be 3 years. The primary outcomes will be changes in caregiver depressive symptoms, measured with the Geriatric Depression Scale, and in caregiver burden using the Zarit caregiver burden interview.
Read the detailed description
The prevalence of dementia is increasing with the aging of the population and the absence of prevention or cure. Thus, the burden of dementia on caregivers is also increasing. Hispanics have a higher prevalence of dementia than non-Hispanic Whites (NHW), have higher caregiving burden, and may have less economic resources to cope with the caregiving burden. However, there is a paucity of evidence on the effectiveness of caregiver interventions in Hispanics. We propose to compare 2 interventions with evidence of efficacy, the New York University Caregiver intervention (NYUCI) and the translated Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT). The NYUCI is a family centered counseling intervention that focuses on reducing negative family interactions and improving family support of the primary caregiver. REACH OUT focuses on caregiver skills training through action-oriented formal problem solving, goal setting, and written action plans. The effectiveness of the NYUCI and the REACH OUT has never been compared. Thus, there is no way for caregivers to decide which intervention to choose. In addition, there is a paucity of data on the effectiveness of both interventions in Hispanics.
- Conditions
- Depressive Symptoms, Burden
- Being tested
- Social work support, Educational material, NYU caregiver counseling intervention, REACH OUT counseling intervention
- Keywords
- Hispanic, Dementia, Caregivers, Depressive symptoms, Burden, Pragmatic randomized trial
- Medical subject headings
- Depression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social work supportOther
All study participants were provided access to social support services at Riverstone Senior Life services
Educational materialOther
All participants received educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
NYU caregiver counseling interventionBehavioural
The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.
REACH OUT counseling interventionBehavioural
All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed
| Study group | Role | What they receive |
|---|---|---|
| NYU Caregiver Intervention | Experimental | The New York University (NYU) caregiver intervention arm received the NYU caregiver intervention in addition to social work support and educational materials. Receives: Other: Social work support; Other: Educational material; Behavioral: NYU caregiver counseling intervention |
| REACH OUT | Active comparator | The Resources for Enhancing Caregiver Health Offering Useful Treatments (REACH OUT) intervention arm received the REACH OUT caregiver intervention in addition to social work support and educational materials. Receives: Other: Social work support; Other: Educational material; Behavioral: REACH OUT counseling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The GDS questions are answered "yes" or "no", instead of a five-category response set. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".Higher scores indicate more depressive symptoms.
Measured: 6 months
Score on Zarit Caregiver Burden Scale
Zarit Caregiver Burden Scale measures caregiver burden by asking caregivers to respond to a series of 22 questions about the impact of the patient's disabilities on their life. For each item, caregivers are to indicate how often they felt that way (never, rarely, sometimes, quite frequently, or nearly always). The Burden Interview is scored by adding the numbered responses of the individual items. Higher scores indicate greater caregiver distress. Estimates of the degree of burden can be made from preliminary findings: 0 - 20 (little or no burden), 21 - 40 (mild to moderate burden), 41 - 60 (moderate to severe burden), and 61 - 88 (severe burden).
Measured: 6 months
Secondary outcomes (4)
Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale
The Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale: For adults, each question has five response options ranging in value from one to five (for pediatrics and parent proxy it is 0 to 4). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Higher scores indicate better health.
Measured: 6 months
Score on Perceived Stress Scale (PSS)
The Perceived Stress Scale is a self-report measure of stress that would be used to measure caregiver stress. The total score is calculated by finding the sum of 10 items, reverse coding questions 4, 5, 7, \& 8. The PSS has a range of scores between 0 and 40. A higher score indicates more stress.
Measured: 6 months
Score on the PROMIS Short Form (SF) Depression Scale
Depressive symptoms measured with the PROMIS SF Depression Scale: Each question has five response options ranging in value from one to five. To find the total raw score, sum the values of the response to each question. For example, for the eight-item form, the lowest possible raw score is 8; the highest possible raw score is 40. The total raw score is then converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score means more depressive symptoms.
Measured: 6 months
Total Score on Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the depression module, which scores each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. The range of the total score of the PHQ-9 is 0 to 27, with higher scores indicating more depressive symptoms.
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 posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew Home at Riverdale, NYU Langone Health, Burgio Geriatric Consulting, Riverstone Senior Life Services, Alzheimer's Association, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, José A. Luchsinger, Columbia University
- Investigators
- Jose A Luchsinger, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092987
- Sponsor's protocol ID
- AAAM5150
- Other IDs
- 7160
- Acronym
- NHiCE
- Status last verified
- Sep 2020
- First submitted
- 19 Mar 2014
- Last updated
- 9 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luchsinger JA, Burgio L, Mittelman M, Dunner I, Levine JA, Kong J, Silver S, Ramirez M, Teresi JA. Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia. BMJ Open. 2016 Nov 25;6(11):e014082. doi: 10.1136/bmjopen-2016-014082.
PubMed 27888180
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
- ClinicalTrials.gov ID
- NCT02092987
- Acronym / sponsor ID
- NHiCE / AAAM5150
- Conditions
- Depressive Symptoms, Burden
- Keywords
- Hispanic, Dementia, Caregivers, Depressive symptoms, Burden, Pragmatic randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Hebrew Home at Riverdale, NYU Langone Health, Burgio Geriatric Consulting, Riverstone Senior Life Services, Alzheimer's Association, Patient-Centered Outcomes Research Institute
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary research question is which of the 2 best known dementia caregiver interventions, the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden among Hispanic caregivers in New York City. The investigators hypothesize that the NYUCI will be more effective than REACH OUT in reducing caregiver depressive symptoms and burden among Hispanics because of its focus on family-centered counseling, which is posited to be more important among Hispanic caregivers because of a cultural emphasis among Hispanics on family interactions in interventions. In order to answer the primary question, the investigators will conduct a pragmatic randomized trial comparing the NYUCI vs. REACH OUT in 200 Hispanic caregivers of persons with dementia in the community of Northern Manhattan. The total time of the intervention will be 6 months.
Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic relative (any relative) caregivers of persons with dementia. Our objective is to obtain effectiveness information that will help caregivers and health providers to make decisions about which intervention to choose. Our primary aim is to compare the effectiveness of the implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and REACH OUT and to examine additional outcomes such as caregiver stress and physical health, and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic randomized trial of 200 relative caregivers of persons with dementia. Participants will be randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6 months, with assessments at baseline and follow-up. All interventions and questionnaires will be conducted in both English and Spanish. The study duration will be 3 years. The primary outcomes will be changes in caregiver depressive symptoms, measured with the Geriatric Depression Scale, and in caregiver burden using the Zarit caregiver burden interview.
Detailed description
The prevalence of dementia is increasing with the aging of the population and the absence of prevention or cure. Thus, the burden of dementia on caregivers is also increasing. Hispanics have a higher prevalence of dementia than non-Hispanic Whites (NHW), have higher caregiving burden, and may have less economic resources to cope with the caregiving burden. However, there is a paucity of evidence on the effectiveness of caregiver interventions in Hispanics. We propose to compare 2 interventions with evidence of efficacy, the New York University Caregiver intervention (NYUCI) and the translated Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT). The NYUCI is a family centered counseling intervention that focuses on reducing negative family interactions and improving family support of the primary caregiver. REACH OUT focuses on caregiver skills training through action-oriented formal problem solving, goal setting, and written action plans. The effectiveness of the NYUCI and the REACH OUT has never been compared. Thus, there is no way for caregivers to decide which intervention to choose. In addition, there is a paucity of data on the effectiveness of both interventions in Hispanics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NYU Caregiver Intervention | Experimental | Other: Social work support, Other: Educational material, Behavioral: NYU caregiver counseling interventionThe New York University (NYU) caregiver intervention arm received the NYU caregiver intervention in addition to social work support and educational materials. |
| REACH OUT | Active comparator | Other: Social work support, Other: Educational material, Behavioral: REACH OUT counseling interventionThe Resources for Enhancing Caregiver Health Offering Useful Treatments (REACH OUT) intervention arm received the REACH OUT caregiver intervention in addition to social work support and educational materials. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self identified Hispanic
- Between the ages of 18 and 90.
- Caregiver is related to persons receiving care either as a spouse (including common law partners) or a blood or in-law relative.
- Person receiving care has been diagnosed with dementia and reports at least 1 memory/cognition and 1 daily functioning symptom in our screening questionnaire (see appendix).
- Caregiver is physically able to provide care
Key exclusion criteria (7 listed)
- Not Hispanic
- Caregiver is not a relative as defined in the inclusion criteria.
- Person receiving care does not have dementia
- Other than depression, caregiver has a major psychiatric disorder such as schizophrenia
- Caregiver has depression with psychotic features or suicidal ideation in the last 5 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 |
|---|---|---|
| Social work supportAll study participants were provided access to social support services at Riverstone Senior Life services | Other | NYU Caregiver Intervention, REACH OUT |
| Educational materialAll participants received educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide. | Other | NYU Caregiver Intervention, REACH OUT |
| NYU caregiver counseling interventionThe first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers. | Behavioural | NYU Caregiver Intervention |
| REACH OUT counseling interventionAll aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed | Behavioural | REACH OUT |
Primary outcome
Score on Geriatric Depression Scale
Time frame: 6 months
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The GDS questions are answered "yes" or "no", instead of a five-category response set. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".Higher scores indicate more depressive symptoms.
Score on Zarit Caregiver Burden Scale
Time frame: 6 months
Zarit Caregiver Burden Scale measures caregiver burden by asking caregivers to respond to a series of 22 questions about the impact of the patient's disabilities on their life. For each item, caregivers are to indicate how often they felt that way (never, rarely, sometimes, quite frequently, or nearly always). The Burden Interview is scored by adding the numbered responses of the individual items. Higher scores indicate greater caregiver distress. Estimates of the degree of burden can be made from preliminary findings: 0 - 20 (little or no burden), 21 - 40 (mild to moderate burden), 41 - 60 (moderate to severe burden), and 61 - 88 (severe burden).
4 secondary outcomes
Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale
Time frame: 6 months
Score on Perceived Stress Scale (PSS)
Time frame: 6 months
Score on the PROMIS Short Form (SF) Depression Scale
Time frame: 6 months
Total Score on Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27888180Luchsinger JA, Burgio L, Mittelman M, Dunner I, Levine JA, Kong J, Silver S, Ramirez M, Teresi JA. Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia. BMJ Open. 2016 Nov 25;6(11):e014082. doi: 10.1136/bmjopen-2016-014082.
- 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.
Jose A Luchsinger, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social work support, Educational material and NYU caregiver counseling intervention in people with Depressive Symptoms and Burden, run by Columbia University 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 9 inclusion and 7 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 9 Jul 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?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score on Geriatric Depression Scale (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT02092987, which also lists 1 linked publication.
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 9 Jul 2021.