Dementia Family Caregiver Burden and Conflict
Conditions
Brief summary
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.
Detailed description
Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.
Interventions
BEHAVIORALTelemental 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
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Either the caregiver or the care-recipient must be a Veteran. The caregiver must: * Be the primary unpaid family or friend who helps or supports an individual with dementia * Be involved in the care of the person with dementia (at least 4 hours of care per day) * Report that the care-recipient exhibits behavioral problems that are distressing * Not be currently receiving the REACH VA protocol Additionally, the care-recipient must: * Must have a documented diagnosis of dementia * Have cognitive impairment (MMSE\<23 or SLUMS\<20 or diagnosis of dementia based on chart review) * Be out of bed and able to respond to a caregiver's instructions or interventions
Exclusion criteria
* Caregiver severe cognitive impairment * Caregiver inability to meet study demands * Caregiver psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthy Aging Brain Center Monitor (HABC Monitor): | Post Treatment, an average of 12-18 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Kansas Marital Conflict Scale (KMCS) | Post Treatment, an average of 12-18 weeks | 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. |
| Patient Health Questionnaire - 9 (PHQ) | Post Treatment, an average of 12-18 weeks | 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). |
| Zarit Burden Scale | Post Treatment, an average of 12-18 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
4 dyads were enrolled
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient enrollment for intervention development | 4 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants |
| Age, Categorical Caregivers >=65 years | 3 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 1 Participants |
| Age, Categorical Patients <=18 years | 0 Participants |
| Age, Categorical Patients >=65 years | 4 Participants |
| Age, Categorical Patients Between 18 and 65 years | 0 Participants |
| Age, Continuous Caregivers | 69 years |
| Age, Continuous Patients | 75 years |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) Caregivers White | 2 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Patients Asian | 0 Participants |
| Race (NIH/OMB) Patients Black or African American | 0 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) Patients White | 2 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Caregivers Female | 4 Participants |
| Sex: Female, Male Caregivers Male | 0 Participants |
| Sex: Female, Male Patients Female | 0 Participants |
| Sex: Female, Male Patients Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Post Treatment, an average of 12-18 weeks
Population: 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.
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).
Time frame: Post Treatment, an average of 12-18 weeks
Population: 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.
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.
Time frame: Post Treatment, an average of 12-18 weeks
Population: 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.
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.
Time frame: Post Treatment, an average of 12-18 weeks
Population: 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.