Clinical trial NCT01194128: Facilitating Caregiver Adaptation to Patient Institutionalization
Official title: Intervention to Facilitate Family Caregiver Adaptation to Nursing Home Transition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia
Stroke
Heart Disease
Keywords: caregivers,
institutionalization,
dementia patients,
bereavement,
grief
complicated grief
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 217
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effects of an intervention targeting family caregivers who recently placed a relative in a long-term care facility because of cognitive and/or physical disability. In a two group randomized clinical trial we predict that caregivers assigned to active treatment will have lower levels of depressive symptoms, anxiety symptoms, and greater satisfaction with the long-term care facility when compared to individuals assigned to the control condition.

Detailed description: This study is designed to address three interrelated needs of caregivers who recently placed a relative in a long-term care facility: (a) psychiatric problems, particularly depression and anxiety which are common among caregivers who recently placed their relative; (b) knowledge about the nature of long-care procedures and resident trajectories; and (c) end-of-life planning for the institutionalized relative. These needs will be addressed with an intervention that has three components: (a) a treatment protocol for depressive symptoms, major depression, and anxiety; (b) education about the organization and operating procedures of long-term care facilities, the clinical aspects of frailty, and a negotiated plan for caregiver participation in the care of their relative; and (c) education about resident trajectories in long-term care and assistance with end-of life planning. Expected outcomes include reduced depression and anxiety, greater satisfaction with the long-term care facility, and reduced service use because of an articulated end-of-life plan. Because this intervention is designed to reduce distress prior to the death of the placed relative, a risk factor for negative bereavement outcomes, we also expect lower levels of depression and complicated grief post-death among persons in the active treatment condition whose relative dies. In as much as the demand and utilization of long-term care is virtually certain to increase in the decades ahead, this study has the potential of providing valuable guidance in navigating this transition and in improving health outcomes for caregivers in the short- and long-term. The specific aims of this study are to:

1. Assess the effects of an intervention targeting caregivers who recently placed a relative in a long-term care facility because of cognitive and/or physical disability. In a two group randomized clinical trial we predict that caregivers assigned to active treatment will have lower levels of depressive symptoms, anxiety symptoms, and greater satisfaction with the long-term care facility when compared to individuals assigned to the control condition.
2. Assess the impact of the intervention on psychiatric outcomes and on complicated grief for those caregivers whose relative dies during follow up. We predict that long-term symptoms of depression and symptoms of complicated grief will be lower after death among caregivers assigned to active treatment when compared to those in the control condition.
3. Carry out exploratory analysis to assess the effects of the intervention on resident-related outcomes, including number of emergency room visits and hospitalizations, rate of functional decline, perceived quality of life, and formal complaints filed on behalf of the resident. Because the intervention engages the caregiver in monitoring resident health status and in end-of-life planning, we predict that resident-related outcomes will be better in the active treatment group. Overall, this should be reflected in greater perceived quality of life of residents in active treatment when compared to residents of participants in the control condition.

Eligibility criteria: Inclusion Criteria: The Caregiver

1. is a family member/partner (e.g., spouse, child, or fictive kin) of institutionalized person;
2. is 21 years of age or older;
3. provided a minimum of 3 months of in-home care prior to institutionalization;
4. speaks English; and
5. plans to live in the area for at least 6 months.

The care recipient/resident must:

(1) be 50 years old or older; and (2) have been permanently placed within a long-term care facility within the last 120 days with impairment in at least 3 of 6 Activities of Daily Living.

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Exclusion Criteria:

(1) care recipient is enrolled in a hospice program.

Primary outcomes:
measure: Depression
timeFrame: 6, 12, and 18 months after baseline assessment
measure: State Anxiety
timeFrame: 6, 12,and 18 months post baseline
measure: Caregiver Burden
timeFrame: 6, 12, and 18 months
measure: Complicated Grief
timeFrame: 6, 12, and 18 months post-baseline
Secondary outcomes:
measure: Prescription medication use
timeFrame: 6,12, and 18 months post-baseline
measure: Social activities
timeFrame: 6, 12, and 18 months post-baseline
measure: Quality of Life AD
timeFrame: 6, 12, and 18 months post-baseline
measure: Texas Revised Inventory of Grief
timeFrame: 6, 12, and 18 months post-baseline
measure: After-death bereaved family member interview (nursing home version)
timeFrame: 6, 12, and 18 months post-baseline
measure: Overall rating scale for patient focused, family centered care
timeFrame: 6, 12, and 18 months post-baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Richard Schulz, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulz R, Rosen J, Klinger J, Musa D, Castle NG, Kane A, Lustig A. Effects of a Psychosocial Intervention on Caregivers of Recently Placed Nursing Home Residents: A Randomized Controlled Trial. Clin Gerontol. 2014 Jan 1;37(4):347-367. doi: 10.1080/07317115.2014.907594.