A Phase 3 interventional study of Psychoeducational Support and Information only control group in Dementia, Stroke and Heart Disease, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Pittsburgh · Phase 3, Interventional, and Treatment
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.
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:
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 217 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Inclusion Criteria: The Caregiver
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.
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
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
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.
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.
Depression
Depressive affect assesed with CES-D
Time frame: 6, 12, and 18 months after baseline assessment
State Anxiety
Assessed general anxiety using the Spielberger et al., state anxiety inventory
Time frame: 6, 12,and 18 months post baseline
Caregiver Burden
Burden as assessed by Bedard et al, adaptation of Zarit Burden interview
Time frame: 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
Time frame: 6, 12, and 18 months post-baseline
Prescription medication use
Prescription medication for depression and anxiety
Time frame: 6,12, and 18 months post-baseline
Social activities
Assesses satisfaction with time spent engagin in social activites, REACH instrument
Time frame: 6, 12, and 18 months post-baseline
Quality of Life AD
Caregivers assessment of the quality of life of AD patient using scale by Logsdon et al.,
Time frame: 6, 12, and 18 months post-baseline
Texas Revised Inventory of Grief
Fashingbauer scale used to assess grief in caregivers who experienced the death of their loved one
Time frame: 6, 12, and 18 months post-baseline
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
Time frame: 6, 12, and 18 months post-baseline
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
Time frame: 6, 12, and 18 months post-baseline
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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