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Facilitating Caregiver Adaptation to Patient Institutionalization

Phase 3
Completed
Conditions
Stroke
Dementia
Heart Disease
Registration Number
NCT01194128
Lead Sponsor
University of Pittsburgh
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
217
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.

Exclusion Criteria

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Complicated Grief6, 12, and 18 months post-baseline

Prigerson et al, complicated grief scale; applies only to caregivers who experience the death of a loved one

Depression6, 12, and 18 months after baseline assessment

Depressive affect assesed with CES-D

State Anxiety6, 12,and 18 months post baseline

Assessed general anxiety using the Spielberger et al., state anxiety inventory

Caregiver Burden6, 12, and 18 months

Burden as assessed by Bedard et al, adaptation of Zarit Burden interview

Secondary Outcome Measures
NameTimeMethod
Prescription medication use6,12, and 18 months post-baseline

Prescription medication for depression and anxiety

Social activities6, 12, and 18 months post-baseline

Assesses satisfaction with time spent engagin in social activites, REACH instrument

Quality of Life AD6, 12, and 18 months post-baseline

Caregivers assessment of the quality of life of AD patient using scale by Logsdon et al.,

Texas Revised Inventory of Grief6, 12, and 18 months post-baseline

Fashingbauer scale used to assess grief in caregivers who experienced the death of their loved one

After-death bereaved family member interview (nursing home version)6, 12, and 18 months post-baseline

Assesses resident care prior to death on four dimensions;used only for caregivers who experience the death of a loved one

Overall rating scale for patient focused, family centered care6, 12, and 18 months post-baseline

Assesses overall communication, respect for patient wishes, symptom control, provided emotional support to family by nursing home staff

Trial Locations

Locations (1)

University of Pittsburgh

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States

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