Facilitating Caregiver Adaptation to Patient Institutionalization

NCT01194128 | Completed Phase 3 DMC

• 1 other identifier: R01NR009573
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Stroke; Heart Disease

Keywords

caregivers,; institutionalization,; dementia patients,; bereavement,; grief; complicated grief

Outcome Measures

Primary Outcomes (4)

• Depression

  Depressive affect assesed with CES-D

  6, 12, and 18 months after baseline assessment

• State Anxiety

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

  6, 12,and 18 months post baseline

• Caregiver Burden

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

  6, 12, and 18 months

• 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

Secondary Outcomes (6)

• Prescription medication use

  6,12, and 18 months post-baseline

• Social activities

  6, 12, and 18 months post-baseline

• Quality of Life AD

  6, 12, and 18 months post-baseline

• Texas Revised Inventory of Grief

  6, 12, and 18 months post-baseline

• After-death bereaved family member interview (nursing home version)

  6, 12, and 18 months post-baseline

Study Arms (2)

Psychoeducatioinal Support

EXPERIMENTAL

The intervention is comprised of three modules (see Table 6), 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.

Behavioral: Psychoeducational Support

INformation only control group

ACTIVE COMPARATOR

Participants in the control group will receive a portion of the standardized packet of written information that is also provided to the treatment group. This packet will contain several fact sheets from a nationally-recognized expert source in caregiving (the Family Caregiver Alliance's National Center on Caregiving) and a national information and advocacy group (the National Citizens' Coalition for Nursing Home Reform). 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.

Behavioral: Information only control group

Interventions

Psychoeducational Support BEHAVIORAL

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.

Psychoeducatioinal Support

Information only control group BEHAVIORAL

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.

INformation only control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is a family member/partner (e.g., spouse, child, or fictive kin) of institutionalized person;
• is 21 years of age or older;
• provided a minimum of 3 months of in-home care prior to institutionalization;
• speaks English; and
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related 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. doi: 10.1080/07317115.2014.907594.

  PMID: 25071302 RESULT

MeSH Terms

Conditions

Dementia; Stroke; Heart Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Schulz, PH.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Psychiatry

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: January 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)