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| ID | Type | Description | Link |
|---|---|---|---|
| I21HX002256 | U.S. NIH Grant/Contract | View source |
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Insufficient recruitment and resources to continue the study
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Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.
Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Caregiver and patient with dementia dyads who receive the family intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemental Health Family Intervention | Behavioral | Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Aging Brain Center Monitor (HABC Monitor): | A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity. | Post Treatment, an average of 12-18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Kansas Marital Conflict Scale (KMCS) | A 37-item self-report scale consisting of three subscales of how well partners are able to: (1) listen and understand each other's perspectives, (2) express his or her point of view , and (3) come to a mutually satisfactory compromise. It has been shown to have high internal consistency ( = .87 to .90) and test-retest reliability (r = .62 to .92). Although developed for marital relationships, all items are applicable or easily modified for a variety of interpersonal relationships. |
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Inclusion Criteria:
Either the caregiver or the care-recipient must be a Veteran.
The caregiver must:
Additionally, the care-recipient must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cory K. Chen, PhD | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010-5011 | United States |
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4 dyads were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Overall Number of Baseline Participants reflects individual participants, not dyads.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The Overall Number of Baseline Participants reflects individual participants, not dyads. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Healthy Aging Brain Center Monitor (HABC Monitor): | A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity. | Not applicable as due to insufficient recruitment, phase I of the project was not completed and so a treatment protocol could not be developed and implemented. No data was obtained as the intervention phase of the study did not begin. | Posted | Post Treatment, an average of 12-18 weeks |
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Not applicable as the intervention was ultimately not provided given the lack of sufficient initial recruitment during phase I of the project which involved development of the intervention.
Not collected as the study did not progress to a phase where the intervention was delivered and so no adverse events were relevant to the sample (as no intervention was delivered).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Caregiver and patient with dementia dyads who receive the family intervention. Telemental Health Family Intervention: Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cory K. Chen | VA New York Harbor Healthcare System | 212-686-7500 | 4002 | cory.chen@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2021 | Dec 22, 2023 | Prot_SAP_000.pdf |
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Family based telemental health intervention that incorporates: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs.
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| Post Treatment, an average of 12-18 weeks |
| Patient Health Questionnaire - 9 (PHQ) | A 9-item self-report scale based on DSM-IV criteria for Major Depressive Disorder, has been shown to have good sensitivity and specificity and is predictive of health outcomes such as sick days, clinic visits, and symptom related difficulty. Internal reliability of the PHQ-9 is excellent ( = 0.89). | Post Treatment, an average of 12-18 weeks |
| Zarit Burden Scale | A 12-item self-report scale shown to have acceptable indices of internal consistency for the two distinct factors of the scale - personal strain and role strain ( =0.88 and =0.78) and a good predictor of caregiver mental health outcomes. | Post Treatment, an average of 12-18 weeks |
| Count of Participants |
| Participants |
|
| Age, Continuous | The Overall Number of Baseline Participants reflects individual participants, not dyads. | Mean | Full Range | years |
|
| Sex: Female, Male | The Overall Number of Baseline Participants reflects individual participants, not dyads. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The Overall Number of Baseline Participants reflects individual participants, not dyads. | Count of Participants | Participants |
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| Race (NIH/OMB) | The Overall Number of Baseline Participants reflects individual participants, not dyads. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | The Kansas Marital Conflict Scale (KMCS) | A 37-item self-report scale consisting of three subscales of how well partners are able to: (1) listen and understand each other's perspectives, (2) express his or her point of view , and (3) come to a mutually satisfactory compromise. It has been shown to have high internal consistency ( = .87 to .90) and test-retest reliability (r = .62 to .92). Although developed for marital relationships, all items are applicable or easily modified for a variety of interpersonal relationships. | Not applicable as due to insufficient recruitment, phase I of the project was not completed and so a treatment protocol could not be developed and implemented. No data was obtained as the intervention phase of the study did not begin. | Posted | Post Treatment, an average of 12-18 weeks |
|
|
| Secondary | Patient Health Questionnaire - 9 (PHQ) | A 9-item self-report scale based on DSM-IV criteria for Major Depressive Disorder, has been shown to have good sensitivity and specificity and is predictive of health outcomes such as sick days, clinic visits, and symptom related difficulty. Internal reliability of the PHQ-9 is excellent ( = 0.89). | Not applicable as due to insufficient recruitment, phase I of the project was not completed and so a treatment protocol could not be developed and implemented. No data was obtained as the intervention phase of the study did not begin. | Posted | Post Treatment, an average of 12-18 weeks |
|
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| Secondary | Zarit Burden Scale | A 12-item self-report scale shown to have acceptable indices of internal consistency for the two distinct factors of the scale - personal strain and role strain ( =0.88 and =0.78) and a good predictor of caregiver mental health outcomes. | Not applicable as due to insufficient recruitment, phase I of the project was not completed and so a treatment protocol could not be developed and implemented. No data was obtained as the intervention phase of the study did not begin. | Posted | Post Treatment, an average of 12-18 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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