The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City

Objectives Dementia prevalence and its burden on families are increasing. Caregivers of persons with dementia have more depression and stress than the general population. Several interventions have proven efficacy in decreasing depression and stress in selected populations of caregivers. Hispanics in New York City tend to have a higher burden of dementia caregiving compared to non-Hispanic whites (NHW) because Hispanics have a higher prevalence of dementia, tend to have high family involvement, and tend to have higher psychosocial and economic stressors. Thus, we chose to test the effectiveness of a dementia caregiving intervention, the New York University Caregiver Intervention (NYUCI), with demonstrated efficacy in spouse caregivers in Hispanic relative caregivers of persons with dementia. Including the community health worker (CHW) intervention in both arms alleviates general psychosocial stressors and allows the assessment of the effectiveness of the intervention. Compared to two original efficacy studies of the NYUCI, which included only spouse caregivers, our study includes all relative caregivers, including common law spouses, children, siblings, a nephew and nieces. This study will be the first randomised trial to test the effectiveness of the NYUCI in Hispanic caregivers including non-spouses. Methods and analysis The design of the study is a randomised controlled trial (RCT). Participants are randomised to two arms: case management by a CHW and an intervention arm including the NYUCI in addition to case management by the CHW. The duration of intervention is 6 months. The main outcomes in the trial are changes in the Geriatric Depression Scale (GDS) and the Zarit Caregiver Burden Scale (ZCBS) from baseline to 6 months. Ethics and dissemination This trial is approved by the Columbia University Medical Center Institutional Review Board (AAAI0022), and funded by the National Institute on Minority Health and Health Disparities. The funding agency has no role in dissemination. Trial Registration www.ClinicalTrials.gov NCT01306695.

[1]  Janet B W Williams,et al.  Diagnostic and Statistical Manual of Mental Disorders , 2013 .

[2]  W. Thies,et al.  2013 Alzheimer's disease facts and figures , 2013, Alzheimer's & Dementia.

[3]  J. Manly,et al.  Type 2 diabetes and ethnic disparities in cognitive impairment. , 2012, Ethnicity & disease.

[4]  Alzheimer’s Association,et al.  2011 Alzheimer’s disease facts and figures , 2011, Alzheimer's & Dementia.

[5]  C. Gelman Learning From Recruitment Challenges: Barriers to Diagnosis, Treatment, and Research Participation for Latinos With Symptoms of Alzheimer's Disease , 2010, Journal of gerontological social work.

[6]  J. DeCoster,et al.  Enhancing Caregiver Health: Findings from the Resources for Enhancing Alzheimer's Caregiver Health II Intervention , 2010, Journal of the American Geriatrics Society.

[7]  Carol Brayne,et al.  Age, neuropathology, and dementia. , 2009, The New England journal of medicine.

[8]  Devan V Mehrotra,et al.  Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? , 2009, Statistics in medicine.

[9]  R. Schulz,et al.  Interpersonal effects of suffering in older adult caregiving relationships. , 2009, Psychology and aging.

[10]  S. Greenfield,et al.  Comparative Effectiveness Research: A Report From the Institute of Medicine , 2009, Annals of Internal Medicine.

[11]  J. Gaugler,et al.  Predictors of change in caregiver burden and depressive symptoms following nursing home admission. , 2009, Psychology and aging.

[12]  Zhehui Luo,et al.  Fixed effects, random effects and GEE: What are the differences? , 2009, Statistics in medicine.

[13]  A. Wallen,et al.  A three-country randomized controlled trial of a psychosocial intervention for caregivers combined with pharmacological treatment for patients with Alzheimer disease: effects on caregiver depression. , 2008, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry.

[14]  W. Haley,et al.  Can Counseling and Support Reduce Burden and Depressive Symptoms in Caregivers of People with Alzheimer's Disease During the Transition to Institutionalization? Results from the New York University Caregiver Intervention Study , 2008, Journal of the American Geriatrics Society.

[15]  Michael E. Ezell,et al.  Identifying Trajectories of Depressive Symptoms for Women Caring for Their Husbands with Dementia , 2008, Journal of the American Geriatrics Society.

[16]  G. Torres,et al.  Use of the Zarit scale for assessing caregiver burden and collapse in caregiving at home in dementias , 2007, International journal of geriatric psychiatry.

[17]  D. Roth,et al.  Preserving health of Alzheimer caregivers: impact of a spouse caregiver intervention. , 2007, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry.

[18]  David J Weiss,et al.  Psychometric Evaluation and Calibration of Health-Related Quality of Life Item Banks: Plans for the Patient-Reported Outcomes Measurement Information System (PROMIS) , 2007, Medical care.

[19]  Richard Schulz,et al.  Enhancing the Quality of Life of Dementia Caregivers from Different Ethnic or Racial Groups , 2006, Annals of Internal Medicine.

[20]  D. Roth,et al.  Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease , 2006, Neurology.

[21]  B. Reeve Special Issues for Building Computerized-Adaptive Tests for Measuring Patient-Reported Outcomes: The National Institute of Health's Investment in New Technology , 2006, Medical care.

[22]  S. Black,et al.  National Institute of Neurological Disorders and Stroke–Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards , 2006, Stroke.

[23]  D. Roth,et al.  Predictors of improvement in social support: Five-year effects of a structured intervention for caregivers of spouses with Alzheimer's disease. , 2006, Social science & medicine.

[24]  E. Dooley National Institute of Neurological Disorders and Stroke , 2006 .

[25]  D. Roth,et al.  Changes in social support as mediators of the impact of a psychosocial intervention for spouse caregivers of persons with Alzheimer's disease. , 2005, Psychology and aging.

[26]  Christianna S. Williams,et al.  Families filling the gap: comparing family involvement for assisted living and nursing home residents with dementia. , 2005, The Gerontologist.

[27]  D. Mahoney,et al.  Dementia Caregiving: The Experiences of Hispanic/Latino Caregivers , 2005, Journal of transcultural nursing : official journal of the Transcultural Nursing Society.

[28]  Richard Schulz,et al.  Long-term care placement of dementia patients and caregiver health and well-being. , 2004, JAMA.

[29]  D. Roth,et al.  Sustained benefit of supportive intervention for depressive symptoms in caregivers of patients with Alzheimer's disease. , 2004, The American journal of psychiatry.

[30]  Joan Wood,et al.  Patient and caregiver characteristics associated with depression in caregivers of patients with dementia , 2003, Journal of General Internal Medicine.

[31]  S. Wisniewski,et al.  The Resources for Enhancing Alzheimer's Caregiver Health (REACH): project design and baseline characteristics. , 2003, Psychology and aging.

[32]  C. Lyketsos,et al.  Prevalence of neuropsychiatric symptoms in dementia and mild cognitive impairment: results from the cardiovascular health study. , 2002, JAMA.

[33]  C. Epstein,et al.  Counseling the Alzheimer's Caregiver: A Resource for Health Care Professionals , 2002 .

[34]  J. Teresi,et al.  Some Statistical Issues in the Analyses of Data From Longitudinal Studies of Elderly Chronic Care Populations , 2002, Psychosomatic medicine.

[35]  Kristine Yaffe,et al.  Patient and caregiver characteristics and nursing home placement in patients with dementia. , 2002, JAMA.

[36]  C. Lyketsos,et al.  Neuropsychiatric disturbance in Alzheimer's disease clusters into three groups: the Cache County study , 2001, International journal of geriatric psychiatry.

[37]  D A Grayson,et al.  Item bias in the Center for Epidemiologic Studies Depression Scale: effects of physical disorders and disability in an elderly community sample. , 2000, The journals of gerontology. Series B, Psychological sciences and social sciences.

[38]  K. Marder,et al.  The APOE- (cid:101) 4 Allele and the Risk of Alzheimer Disease Among African Americans, Whites, and Hispanics , 2001 .

[39]  R B D'Agostino,et al.  Lifetime risk of dementia and Alzheimer's disease , 1997, Neurology.

[40]  K Y Liang,et al.  Sample size calculations for studies with correlated observations. , 1997, Biometrics.

[41]  D. Follmann Multivariate tests for multiple endpoints in clinical trials. , 1995, Statistics in Medicine.

[42]  P. Diggle Analysis of Longitudinal Data , 1995 .

[43]  P. Truax,et al.  Assessment of behavioral problems in dementia: the revised memory and behavior problems checklist. , 1992, Psychology and aging.

[44]  M. Albert,et al.  Prevalence of Alzheimer's disease in a community population of older persons. Higher than previously reported. , 1989, JAMA.

[45]  J. Fleiss The design and analysis of clinical experiments , 1987 .

[46]  J. Stokes,et al.  Toward an understanding of cohesion in personal change groups. , 1983, International journal of group psychotherapy.

[47]  B. Reisberg,et al.  The Global Deterioration Scale for assessment of primary degenerative dementia. , 1982, The American journal of psychiatry.

[48]  S. Zarit,et al.  Relatives of the impaired elderly: correlates of feelings of burden. , 1980, The Gerontologist.

[49]  L. Radloff The CES-D Scale , 1977 .

[50]  D. Selkoe Alzheimer's disease. , 2011, Cold Spring Harbor perspectives in biology.

[51]  J. Teresi,et al.  Occurrences and sources of Differential Item Functioning (DIF) in patient-reported outcome measures: Description of DIF methods, and review of measures of depression, quality of life and general health. , 2008, Psychology science quarterly.

[52]  D. Roth,et al.  Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. , 2004, The journals of gerontology. Series B, Psychological sciences and social sciences.

[53]  R. Hu Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) , 2003 .

[54]  R. Cassidy,et al.  Overview of Race and Hispanic Origin: 2000 , 2001 .

[55]  A. Stewart,et al.  Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. , 1999, Medical care.

[56]  C. Lyketsos,et al.  Major and minor depression in Alzheimer's disease: prevalence and impact. , 1997, The Journal of neuropsychiatry and clinical neurosciences.

[57]  J. F. Fitzgerald,et al.  Replication of the multidimensionality of activities of daily living. , 1993, Journal of gerontology.

[58]  V. Leirer,et al.  Development and validation of a geriatric depression screening scale: a preliminary report. , 1982, Journal of psychiatric research.