DementiaPhase 3FACTSNCT01194128
Facilitating Caregiver Adaptation to Patient Institutionalization
A Phase 3 study testing Psychoeducational Support in people with Dementia and Stroke, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Stroke, Heart Disease
- What is being tested?
- Psychoeducational Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- -
Who cannot join
- care recipient is enrolled in a hospice program.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Intervention to Facilitate Family Caregiver Adaptation to Nursing Home Transition
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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Dementia, Stroke, Heart Disease
- Being tested
- Psychoeducational Support, Information only control group
- Keywords
- caregivers,, institutionalization,, dementia patients,, bereavement,, grief, complicated grief
- Medical subject headings
- Dementia, Stroke, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational SupportBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Information only control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depressive affect assesed with CES-D
Measured: 6, 12, and 18 months after baseline assessment
State Anxiety
Assessed general anxiety using the Spielberger et al., state anxiety inventory
Measured: 6, 12,and 18 months post baseline
Caregiver Burden
Burden as assessed by Bedard et al, adaptation of Zarit Burden interview
Measured: 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
Measured: 6, 12, and 18 months post-baseline
Secondary outcomes (6)
Prescription medication use
Prescription medication for depression and anxiety
Measured: 6,12, and 18 months post-baseline
Social activities
Assesses satisfaction with time spent engagin in social activites, REACH instrument
Measured: 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.,
Measured: 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
Measured: 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
Measured: 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
Measured: 6, 12, and 18 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Schulz, University of Pittsburgh
- Investigators
- Richard Schulz, PH.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194128
- Sponsor's protocol ID
- R01NR009573
- Acronym
- FACTS
- Status last verified
- Nov 2015
- First submitted
- 1 Sep 2010
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25071302
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Facilitate Family Caregiver Adaptation to Nursing Home Transition
- ClinicalTrials.gov ID
- NCT01194128
- Acronym / sponsor ID
- FACTS / R01NR009573
- Conditions
- Dementia, Stroke, Heart Disease
- Keywords
- caregivers,, institutionalization,, dementia patients,, bereavement,, grief, complicated grief
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducatioinal Support | Experimental | Behavioral: Psychoeducational SupportThe 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. |
| INformation only control group | Active comparator | Behavioral: Information only control groupParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- care recipient is enrolled in a hospice program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational SupportThe 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. | Behavioural | Psychoeducatioinal Support |
| Information only control groupParticipants 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. | Behavioural | INformation only control group |
Primary outcome
Depression
Time frame: 6, 12, and 18 months after baseline assessment
Depressive affect assesed with CES-D
State Anxiety
Time frame: 6, 12,and 18 months post baseline
Assessed general anxiety using the Spielberger et al., state anxiety inventory
Caregiver Burden
Time frame: 6, 12, and 18 months
Burden as assessed by Bedard et al, adaptation of Zarit Burden interview
Complicated Grief
Time frame: 6, 12, and 18 months post-baseline
Prigerson et al, complicated grief scale; applies only to caregivers who experience the death of a loved one
6 secondary outcomes
Prescription medication use
Time frame: 6,12, and 18 months post-baseline
Social activities
Time frame: 6, 12, and 18 months post-baseline
Quality of Life AD
Time frame: 6, 12, and 18 months post-baseline
Texas Revised Inventory of Grief
Time frame: 6, 12, and 18 months post-baseline
After-death bereaved family member interview (nursing home version)
Time frame: 6, 12, and 18 months post-baseline
Overall rating scale for patient focused, family centered care
Time frame: 6, 12, and 18 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Results publication: PubMed 25071302Schulz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schulz, PH.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Psychoeducational Support in people with Dementia and Stroke, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 6, 12, and 18 months after baseline assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01194128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.