Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Facilitating Caregiver Adaptation to Patient Institutionalization (FACTS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01194128
First received: September 1, 2010
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Dementia
Stroke
Heart Disease
Behavioral: Psychoeducational Support
Behavioral: Information only control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention to Facilitate Family Caregiver Adaptation to Nursing Home Transition

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Depression [ Time Frame: 6, 12, and 18 months after baseline assessment ] [ Designated as safety issue: Yes ]
    Depressive affect assesed with CES-D

  • State Anxiety [ Time Frame: 6, 12,and 18 months post baseline ] [ Designated as safety issue: No ]
    Assessed general anxiety using the Spielberger et al., state anxiety inventory

  • Caregiver Burden [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Burden as assessed by Bedard et al, adaptation of Zarit Burden interview

  • Complicated Grief [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    Prigerson et al, complicated grief scale; applies only to caregivers who experience the death of a loved one


Secondary Outcome Measures:
  • Prescription medication use [ Time Frame: 6,12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    Prescription medication for depression and anxiety

  • Social activities [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    Assesses satisfaction with time spent engagin in social activites, REACH instrument

  • Quality of Life AD [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    Caregivers assessment of the quality of life of AD patient using scale by Logsdon et al.,

  • Texas Revised Inventory of Grief [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    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 care [ Time Frame: 6, 12, and 18 months post-baseline ] [ Designated as safety issue: No ]
    Assesses overall communication, respect for patient wishes, symptom control, provided emotional support to family by nursing home staff


Estimated Enrollment: 216
Study Start Date: January 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychoeducatioinal Support
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
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.
Active Comparator: 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. 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
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

-

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194128

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Richard Schulz, PH.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Richard Schulz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01194128     History of Changes
Other Study ID Numbers: R01 NR009573
Study First Received: September 1, 2010
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
caregivers,
institutionalization,
dementia patients,
bereavement,
grief
complicated grief

Additional relevant MeSH terms:
Dementia
Heart Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014