Facilitating Caregiver Adaptation to Patient Institutionalization

Stroke Clinical Trial

— FACTS  

Official title:

Intervention to Facilitate Family Caregiver Adaptation to Nursing Home Transition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194128
• Other study ID #: R01NR009573
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2010
• Last updated: November 30, 2015
• Start date: January 2008
• Est. completion date: March 2013

Study information

• Verified date: November 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Heart Disease
• Stroke

Intervention

Behavioral:
• Psychoeducational Support
The intervention is comprised of three modules, each of which has multiple components. Module One provides basic education about the clinical aspects of frailty as well as the organization and operating procedures of long-term care facilities. Module Two focuses on advanced care planning, and Module Three is designed to improve the emotional well-being of family caregivers. The intervention will be delivered via 11 sessions lasting approximately 90 minutes each distributed over a six-month period. All family caregivers will begin with the Basic Knowledge Module. Modules Two and Three will be delivered in alternating sessions, based on caregiver need and preference, a strategy successfully used in the REACH intervention trial.
• Information only control group
Participants in the control group will receive a portion of the standardized packet of written information that is also provided to the treatment group. The fact sheets are relevant to the placement of a family member into a nursing home and are linked to the content areas covered in the intervention. Documents in this packet include "Caregiving and Depression," "End of Life Decision Making," and "Taking Care of You: Self-Care for Family Caregivers" from the Family Caregiver Alliance; and "Family Involvement in Nursing Home Care," "Problem Solving," and "Residents' Rights" from the National Citizen's Coalition. Also provided will be a resource guide containing local contact information.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Depressive affect assesed with CES-D	6, 12, and 18 months after baseline assessment	Yes
Primary	State Anxiety	Assessed general anxiety using the Spielberger et al., state anxiety inventory	6, 12,and 18 months post baseline	No
Primary	Caregiver Burden	Burden as assessed by Bedard et al, adaptation of Zarit Burden interview	6, 12, and 18 months	No
Primary	Complicated Grief	Prigerson et al, complicated grief scale; applies only to caregivers who experience the death of a loved one	6, 12, and 18 months post-baseline	No
Secondary	Prescription medication use	Prescription medication for depression and anxiety	6,12, and 18 months post-baseline	No
Secondary	Social activities	Assesses satisfaction with time spent engagin in social activites, REACH instrument	6, 12, and 18 months post-baseline	No
Secondary	Quality of Life AD	Caregivers assessment of the quality of life of AD patient using scale by Logsdon et al.,	6, 12, and 18 months post-baseline	No
Secondary	Texas Revised Inventory of Grief	Fashingbauer scale used to assess grief in caregivers who experienced the death of their loved one	6, 12, and 18 months post-baseline	No
Secondary	After-death bereaved family member interview (nursing home version)	Assesses resident care prior to death on four dimensions;used only for caregivers who experience the death of a loved one	6, 12, and 18 months post-baseline	No
Secondary	Overall rating scale for patient focused, family centered care	Assesses overall communication, respect for patient wishes, symptom control, provided emotional support to family by nursing home staff	6, 12, and 18 months post-baseline	No