Laraine Winter

Enhancing the Quality of Life of Dementia Caregivers from Different Ethnic or Racial Groups: A Randomized, Controlled Trial

Context Providing care for patients with dementia can pose enormous burdens that may be eased with assistance and support. Needs may differ by race or ethnicity. Contributions The investigators randomly assigned Hispanic, black, and white dementia caregivers to receive written educational materials or an intensive intervention to improve caregiver quality of life. The specific interventions were determined by caregivers, were delivered via trained personnel and telephone support groups, and targeted several dimensions of need. The study found that quality of life improved for Hispanic and white caregivers and for black spousal caregivers in the intervention group but not in the control group. The intervention had no detectable effect on the number of care recipients who were institutionalized. Cautions The study used only a single 6-month follow-up assessment, combined heterogeneous cultures and ethnicities into 3 groups, and excluded some ethnicities. Implications An intensive intervention targeting several dimensions of caregiver need improved caregiver quality of life without an apparent effect on care recipient institutionalization. The effect did not differ by caregiver race or ethnicity. The Editors Caring for a family member with dementia is extremely stressful, contributes to psychiatric and physical illness, and increases the risk for death (1, 2). The accumulating evidence on the personal, social, and health effects of dementia caregiving has generated a broad range of intervention studies, including randomized trials aimed at decreasing the burden and stress of caregiving. Several studies have demonstrated statistically significant effects in reducing caregiver burden, lowering caregiver depression, and delaying institutionalization of care recipients (1, 3, 4) through either targeted interventions that treat a specific caregiver problem, such as depression, or broad-based multicomponent interventions that include counseling, case management, and telephone support. Persistent limitations of caregiver intervention research are the paucity of well-controlled randomized trials, the limited range of outcomes examined, small sample sizes and insufficient power, geographic limitations, inadequate racial or ethnic variation, and a scarcity of comprehensive multicomponent interventions (4). Indeed, none of the 41 randomized clinical trials published in the last 5 years met Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized trials (5), and many have serious methodologic problems that call into question the reported findings (4). To address these limitations, the National Institute on Aging and the National Institute of Nursing Research funded a multisite research program designed to develop and test an effective caregiver intervention: the Resources for Enhancing Alzheimers Caregiver Health (REACH) study. We performed the study in 2 phases. In the first phase (REACH I), we tested several different interventions at 6 U.S. sites to identify the most promising approaches to decreasing caregiver burden and depression (6). Results from the study showed that active treatments were superior to control conditions in reducing caregiver burden and that active engagement in skills training statistically significantly reduced caregiver depression (7, 8). The existing literature and findings from REACH I helped guide the design of the REACH II intervention (7, 8). We based the REACH II study on the premise that caregivers can have problems in several areas at varying levels of intensity, and thus, interventions must be responsive to variations in needs among caregivers. The findings from REACH I also suggest that interventions that use active techniques, such as role-playing and interactive practice, are more effective at improving outcomes, such as depression symptoms, compared with more passive methods, such as providing information (7). We based the REACH II intervention on these assumptions and designed the intervention to maximize outcomes by systematically targeting several problem areas, tailored the intervention to respond to the needs of each individual, and actively engaged the caregiver in the intervention process. We hypothesized that participants assigned to the intervention would do better than those in the control group on several indicators of caregiver quality of life, including depression, burden, self-care, and social support and care recipient problem behaviors, and that these differences would be largest among Hispanic or Latino persons because they have lower access to support services (8). In additional analyses, we assessed the effects of treatment on rates of caregiver clinical depression and care recipient institutional placement, as well as the benefits derived from study participation. Methods Caregivers Eligibility criteria for caregivers included the following: Hispanic or Latino, white or Caucasian, or black or African-American race or ethnicity; age 21 years or older; living with or sharing cooking facilities with the care recipient; providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours per day for at least the past 6 months; and reported distress associated with caregiving (reported at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined). We excluded caregivers who were involved in another caregiver intervention study, who had participated in REACH I, or who had an illness that would prevent 6 months of study participation. Other requirements were logistic, including having a telephone, planning to remain in the geographic area for at least 6 months, and competency in either English or Spanish (see Appendix Table 1 for a detailed list of exclusions). Appendix Table 1. Reasons for Ineligibility Care Recipients To be eligible for the study, caregivers had to confirm that their relative had diagnosed Alzheimer disease or related disorders. In addition, we screened care recipients for a history of severe mental illness, head injury, Parkinson disease, or stroke, and we administered the MiniMental State Examination (MMSE) (9). We excluded patients who were bedbound with MMSE scores of 0 because we felt that our intervention had little to offer caregivers who were caring for such patients. Moreover, being bedbound is a risk factor for institutional placement or death, and we sought to exclude caregivers who were likely to transition out of the caregiving role within the 6-month study. For patients who scored more than 23 on the MMSE or had other conditions, such as head injury, we required a physicians diagnosis of Alzheimer disease or related disorders. Procedures We recruited caregiver and care recipient dyads at 5 sites: Birmingham, Alabama; Memphis, Tennessee; Miami, Florida; Palo Alto, California; and Philadelphia, Pennsylvania. Enrollment began in June 2002, and follow-up ended in August 2004. Recruitment occurred in memory disorder clinics, primary care clinics, social service agencies, physician offices, churches, and community centers and by using professionally designed brochures, public service announcements on radio stations, newspaper articles, television, targeted newsletters, and community presentations. We translated all intervention materials and assessment instruments into Spanish for the Hispanic or Latino participants by using established techniques for forward-and-back translation and allowing for regional variation in language expression. We used bilingual and bicultural staff at the 3 sites that recruited Hispanic or Latino participants: Palo Alto, Philadelphia, and Miami. At all sites, assessors and interventionists received cultural sensitivity training and were certified before entering the field. Certified assessors were blinded to group assignment of study participants. The institutional review boards of all 5 site institutions and the coordinating center in Pittsburgh, Pennsylvania, approved the study. We obtained written informed consent from all caregivers and from care recipients whenever possible. Caregivers provided consent on behalf of care recipients who could not do so on their own. After telephone screening (n= 995) and baseline assessment (n= 670), we randomly assigned participants (n= 642) to the intervention or control group (Figure). We stratified randomization by using a block size of 2 or 4 within strata defined by the 5 intervention sites, 3 racial or ethnic groups (Hispanic or Latino, white or Caucasian, and black or African American), and 2 caregivercare recipient relationships (spouse or nonspouse). We performed randomization at the coordinating center by using a computer-generated algorithm and a standard protocol for transmitting randomization information between the coordinating center and the study sites. We administered 1 of 3 follow-up batteries, on the basis of care recipient status at follow-up (full follow-up, bereavement battery, or placement battery), to study participants 6 months after randomization when the intervention was completed. To maximize the number of individuals who could be included in the outcome analyses, we ensured that the 3 batteries were as similar as possible. We did not ask caregivers about caregiver burden and care recipient functional status if their care recipients had died; thus, we could not include these caregivers in the primary outcome analysis (10). Figure. Study flow diagram. *See Appendix Table 1 for reasons for ineligibility. See Appendix Table 2 (for reasons for unavailable end points and types of 6-month follow-up. Appendix Table 2. Reasons for Unavailable End Points and Types of 6-Month Follow-up Trial Groups Intervention The intervention involved a range of strategies: provision of informat

A Randomized Trial of a Multicomponent Home Intervention to Reduce Functional Difficulties in Older Adults

OBJECTIVES: To test the efficacy of a multicomponent intervention to reduce functional difficulties, fear of falling, and home hazards and enhance self‐efficacy and adaptive coping in older adults with chronic conditions.

A Biobehavioral Home-Based Intervention and the Well-being of Patients With Dementia and Their Caregivers: The COPE Randomized Trial

CONTEXT Optimal treatment to postpone functional decline in patients with dementia is not established. OBJECTIVE To test a nonpharmacologic intervention realigning environmental demands with patient capabilities. DESIGN, SETTING, AND PARTICIPANTS Prospective 2-group randomized trial (Care of Persons with Dementia in their Environments [COPE]) involving patients with dementia and family caregivers (community-living dyads) recruited from March 2006 through June 2008 in Pennsylvania. INTERVENTIONS Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits; obtained blood and urine samples; and trained families in home safety, simplifying tasks, and stress reduction. Control group caregivers received 3 telephone calls and educational materials. MAIN OUTCOME MEASURES Functional dependence, quality of life, frequency of agitated behaviors, and engagement for patients and well-being, confidence using activities, and perceived benefits for caregivers at 4 months. RESULTS Of 284 dyads screened, 270 (95%) were eligible and 237 (88%) randomized. Data were collected from 209 dyads (88%) at 4 months and 173 (73%) at 9 months. At 4 months, compared with controls, COPE patients had less functional dependence (adjusted mean difference, 0.24; 95% CI, 0.03-0.44; P = .02; Cohen d = 0.21) and less dependence in instrumental activities of daily living (adjusted mean difference, 0.32; 95% CI, 0.09-0.55; P = .007; Cohen d = 0.43), measured by a 15-item scale modeled after the Functional Independence Measure; COPE patients also had improved engagement (adjusted mean difference, 0.12; 95% CI, 0.07-0.22; P = .03; Cohen d = 0.26), measured by a 5-item scale. COPE caregivers improved in their well-being (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.08-0.36; P = .002; Cohen d = 0.30) and confidence using activities (adjusted mean difference, 0.81; 95% CI, 0.30-1.32; P = .002; Cohen d = 0.54), measured by a 5-item scale. By 4 months, 64 COPE dyads (62.7%) vs 48 control group dyads (44.9%) eliminated 1 or more caregiver-identified problems (chi(2/1) = 6.72, P = . 01). CONCLUSION Among community-living dyads, a nonpharmacologic biobehavioral environmental intervention compared with control resulted in better outcomes for COPE dyads at 4 months. Although no group differences were observed at 9 months for patients, COPE caregivers perceived greater benefits. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00259454.

Targeting and managing behavioral symptoms in individuals with dementia: a randomized trial of a nonpharmacological intervention.

OBJECTIVES: To test the effects of an intervention that helps families manage distressing behaviors in family members with dementia.

Effect of an In-Home Occupational and Physical Therapy Intervention on Reducing Mortality in Functionally Vulnerable Older People: Preliminary Findings

OBJECTIVES: To evaluate the effect of a multicomponent intervention on mortality and the role of control‐oriented strategy use as the change mechanism.

Affect and quality of life: objective and subjective.

Objectives:The objective of this article is to determine direct and indirect contributions of objective and subjective quality of life (QOL) to positive and negative indicators of mental health. Specifically, the dual-channel hypothesis predicted that objective and subjective social engagement would enhance positive affect (PA) but be unrelated to depression. Methods:Older people from senior centers and several housing environments volunteered to complete a questionnaire or interview about a number of aspects of their everyday lives (N= 602). Objective and subjective were related to one another. Results:Objective activity participation and subjective time use and friend quality were associated with PA. Only time use was related to depression. Discussion:The importance of assessing both amount of behavior (objective) and its quality (subjective) when measuring QOL was demonstrated. Although external engagement bears a closer relationship to PA than to negative, the dual-channel model relating locus of stimulation differentially to PA and depression requires modification.

The Tailored Activity Program to Reduce Behavioral Symptoms in Individuals With Dementia: Feasibility, Acceptability, and Replication Potential

PURPOSE The Tailored Activity Program (TAP) is a home-based occupational therapy intervention shown to reduce behavioral symptoms and caregiver burden in a randomized trial. This article describes TAP, its assessments, acceptability, and replication potential. DESIGN AND METHODS TAP involves 8 sessions for a period of 4 months. Interventionists identify preserved capabilities, previous roles, habits, and interests of individuals with dementia; develop activities customized to individual profiles; and train families in activity use. Interventionists documented time spent and ease conducting assessments, and observed receptivity of TAP. For each implemented prescribed activity, caregivers reported the amount of time their relative spent in activity and perceived benefits. RESULTS The TAP assessment, a combination of neuropsychological tests, standardized performance-based observations, and clinical interviewing, yielded information on capabilities from which to identify and tailor activities. Assessments were easy to administer, taking an average of two 1-hr sessions. Of 170 prescribed activities, 81.5% were used, for an average of 4 times for 23 min by families between treatment sessions for a period of months. Caregivers reported high confidence in using activities, being less upset with behavioral symptoms (86%), and enhanced skills (93%) and personal control (95%). Interventionists observed enhanced engagement (100%) and pleasure (98%) in individuals with dementia during sessions. IMPLICATIONS TAP offers families knowledge of their relatives capabilities and easy-to-use activities. The program was well received by caregivers. Prescribed activities appeared to be pleasurable and engaging to individuals with dementia. TAP merits further evaluation to establish efficacy with larger more diverse populations and consideration as a nonpharmacological approach to manage behavioral symptoms.

Evaluation of a Telephone-Based Support Group Intervention for Female Caregivers of Community-Dwelling Individuals With Dementia

Family caregivers, the “second victims” or hidden patients in dementia care, are at risk for social isolation, stress, depression, and mortality. Telephone-based support (telesupport groups) represents a practical, low-burden, low-cost source of emotional support. The present study evaluated the feasibility and effectiveness of professionally led telephone-based support groups for female family caregivers of community-dwelling dementia patients. Recruited through various community sources, 103 female caregivers were randomized to the telesupport group treatment or a control condition. Effects on caregiver burden, depression, and personal gains were evaluated at 6 months, the main end point. Older care-givers (≥65) in telesupport reported lower depression than control group caregivers did.

Long-term effect on mortality of a home intervention that reduces functional difficulties in older adults: results from a randomized trial.

OBJECTIVES: To evaluate the long‐term mortality effect of a home‐based intervention previously shown to reduce functional difficulties and whether survivorship benefits differ according to initial mortality risk level.

The State of Advance Care Planning: One Decade After SUPPORT:

The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT) was a landmark study regarding end-of-life decision making and advance care planning. Phase I of the study looked at the state of end of life in various hospitals, and phase II implemented a nurse-facilitated intervention designed to improve advance care planning, patient-physician communication, and the dying process. The observational phase found poor quality of care at the end of life and the intervention failed to improve the targeted outcomes. The negative findings brought public attention to the need to improve care for the dying and spawned a wealth of additional research on decision-making at the end of life. In the decade since SUPPORT, researchers have defined the attributes of a “good death,” addressed the role of advance directives in advance care planning, and studied the use of surrogate decision-making at the end of life. This rekindled the discussion on advance care planning and challenged health care providers to design more flexible approaches to end of life care.