Chronic Grief, Dementia Family Caregivers
Conditions
Keywords
online group intervention
Brief summary
The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms, dissatisfaction with care, and conflict with long-term care facility staff. This study will test the effects of a cost effective chronic grief management intervention to be delivered using an online platform (Adobe Connect) and iPads. The study aims to decrease dementia caregivers' chronic grief, depressive and anxiety symptoms, and to improve their positive states of mind; to improve satisfaction with care post-placement and to attenuate caregivers' conflict with facility staff.
Detailed description
Evidence indicates that Alzheimer's disease or a related dementia (ADRD) family caregivers suffer long-term mental and physical health effects that place them at risk for premature death. They do not relinquish their role after placing a family member with Alzheimer's disease or a related dementia (ADRD) in long-term care. In fact, these caregivers experience increased symptoms of depression, symptoms of anxiety, and chronic grief post-placement. In the long-term care (LTC) environment, caregivers' chronic grief is exacerbated by their lack of knowledge about late-stage Alzheimer's disease or a related dementia (ADRD) and their sense of loss, guilt, and role captivity. Interventions targeting improvement of ADRD caregivers' mental health have focused overwhelmingly on in-home care. We tested a Chronic Grief Management Intervention (CGMI) with ADRD caregivers in in long-term care and found it feasible (recruitment, retention, and attendance). The Chronic Grief Management Intervention (CGMI) had significant effects on caregiver knowledge and mental health outcomes (heartfelt sadness/longing and guilt; aspects of chronic grief). Although caregivers reported high satisfaction with this intervention, many could not attend the 12 face-to-face group sessions due to the burden of time and competing responsibilities. Therefore, we reduced the number of sessions to 8 and adapted the Chronic Grief Management Intervention to be delivered as a live streaming video, online group intervention; Chronic Grief Management Intervention-Video (CGMI-V), using Adobe Connect (online platform) and iPads. We tested CGMI-V in a single group pilot study for feasibility (recruitment, retention, attendance and technology ease of use) with Alzheimer's disease or a related dementia (ADRD) caregivers post-placement. We obtained 100% retention with high caregiver satisfaction with the intervention and the online technology used to deliver it. Our proposed study, Chronic Grief Management: A Live Streaming Video, Online Intervention (CGMI-V) builds on these results and is guided by a Model of Dementia Caregiver Chronic Grief in the Long-Term Care Setting. The purpose of this study is to test the effects of the 8-week CGMI-V on a caregiver primary outcome (chronic grief); a secondary mental health outcome (symptoms of depression, symptoms of anxiety, and positive states of mind) and a secondary facility-related outcome (caregiver satisfaction with care and conflict with facility staff) related to a minimal treatment (MT) control group. We propose to test the group-based Chronic Grief Management Intervention-Video (CGMI-V) in a Stage I longitudinal, randomized clinical trial. 144 Alzheimer's disease or a related dementia (ADRD) caregivers whose family members reside in one of the participating long-term care facilities will be randomly assigned to either CGMI-V or MT condition. Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in 8 weekly live streaming video, online group sessions. Caregivers in the minimal treatment (MT) condition will receive written information about late-stage ADRD at baseline. For both conditions, data will be collected at baseline, 8 weeks (immediately post-intervention) and then at 24 weeks post-baseline, using measures of caregiver grief: Marwit-Meuser Caregiver Grief Inventory(MM-CGI); depressive symptoms: Center for Epidemiological Studies Depression Scale (CES-D); anxiety symptoms: Stait-Trait Anxiety Inventory (STAI); positive states of mind: Positive States of Mind Scale (POSMS); satisfaction with care: Family Perception of Care Tool (FPCT); conflict with facility staff: Family Perception of Caregiving Role (FPCR subscale), knowledge of Alzheimer's disease: Family Knowledge of Alzheimer's Test (FKAT), loss, guilt and role captivity (FPCR subscales). Specific aims are to: 1) Establish effect sizes of the Chronic Grief Management Intervention-Video (CGMI-V) condition and Minimal Treatment (MT) control condition on changes in caregiver chronic grief. 2) Establish effect sizes of the CGMI-V and Minimal Treatment (MT) control condition on changes in caregiver symptoms of depression and anxiety and on positive states of mind. 3) Establish effect sizes of the CGMI-V condition and the Minimal Treatment (MT) control condition on changes in caregiver satisfaction with care provided in the facility and conflict with staff, and 4) Explore mechanisms of intervention impact on all caregiver outcomes. Our long-term objective is to develop a chronic grief treatment modality that will be adopted in long-term care facilities as part of routine support for Alzheimer's disease or a related dementia caregivers post-placement. This in turn will impact public mental health for this growing segment of the population.
Interventions
BEHAVIORALChronic Grief Management Intervention-Video
The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.
Intervention model description
Study Design The study is a Stage I longitudinal randomized clinical trial. Alzheimer's disease or a related dementia (ADRD) caregivers whose family members are in long-term care facilities will be recruited, screened for inclusion criteria, and will be randomly assigned to either Chronic Grief Management Intervention-Video (CGMI-V) or a Minimal Treatment (MT) condition. Caregivers in the CGMI-V condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. Those caregivers in the MT condition will receive written information materials about late-stage ADRD at baseline. For both conditions, data will be collected at baseline (pre-intervention), 8 weeks (immediately post-intervention) for intervention effects, and 24 week post baseline for maintenance effects. The design for this study was chosen to avoid the type of group clustering or contamination that would be engendered by the use of a randomized cluster design.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 21 years of age or older * Identified as family member, fictive kin (self-identified family member), or partner of care recipient at any time post permanent placement of care in long-term care facility (LTCF) * Care recipient has a documented ADRD diagnosis and resides in any type of unit in a LTCF * Possessing self-reported basic computer literacy and in-home internet access * Able to speak, read, and write English * Not currently attending another ADRD caregiver grief management group * Experiencing high to moderate levels of grief per screening with the Marwit-Meuser Caregiver Grief Inventory-Short Form (MMCGI-SF) (70 and above); and/or * Experiencing high levels of depressive symptoms per screening with Patient Health Questionnaire-9 (PHQ-9) (scores 10 and above)
Exclusion criteria
* Non English speaker, reader, writer * Scoring under the cut off points on the MM-CGI-SF and the PHQ-9 * Reporting no basic computer literacy; no internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marwit-Meuser Caregiver Grief Inventory (MM-CGI) | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | Center for Epidemiological Studies Depression Scale (CES-D). The CES-D was assessed with 20-items, where responses are based on a four-point frequency rating (0 = rarely or none of the time to 3 = all of the time), with a possible range of 0 to 60. Larger scores represent more depressive symptoms, lower scores represent fewer symptoms. |
| Change in Anxiety Symptoms | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | State-Trait Anxiety Inventory (STAI) was used to represent anxiety symptoms. The (STAI) includes 20 questions, with responses based on a scale of 1 to 4 (1 = almost never to 4 = almost always). Numeric responses to these questions are summed to produce an inventory score, with a possible range of 20-80, where higher scores indicate greater anxiety, and lower scores indicate less anxiety. |
| Change in Positive States of Mind | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | Positive States of Mind Scale (PSOMS) was used to assess the extent to which caregivers were able to achieve six positive states of mind in the previous seven days. PSOM is based on 6 questions that are scored 0-4 and which are summed to produce scale scores that range from 0-24. Lower scores represent difficulty achieving positive states of mind in the past 7 days, higher scores indicate less difficulty achieving positive states of mind. |
| Change in Conflict With Facility Staff | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | Conflict with facility staff was assessed with a subscale of 10 questions collected in the Family Perception of Caregiving Role (FPCR) tool. Scores on these 10 questions ranged from 1 (strongly disagree) to 7 (strongly agree). Response values associated with conflict subscale items were summed to produce total conflict scores ranging from 10-70. Lower scores indicate less conflict with facility staff, higher scores indicate more conflict with facility staff. |
| Change in Satisfaction With Care | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | The Family Perception of Care Tool (FPCT) is comprised of 51 questions with 7-point likert-type responses where 1=strongly agree and 7=strongly disagree. When summed to create a total FPCT score, values ranged from 51-357. Higher scores in the FPCT represent more positive feelings towards staff whereas lower scores represent more negative feelings. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Knowledge of Alzheimer's Disease | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | Family Knowledge of Alzheimer's Tool (FKAT) captures what a family caregiver knows about the disease process, how the care recipient is behaving, and how the long-term care facility (LTCF) is caring for him or her. Responses are based on a true/false scale, with scores ranging from 0 to 22 correct answers; larger scores indicate greater knowledge about AD, lower scores indicate less knowledge about AD. |
| Change in Caregiver Sense of Loss, Guilt, and Role Captivity | Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported. | The Revised Family Perceptions of Caregiving Role (FPCR) instrument includes subscales for Loss, Guilt, Role Captivity, and Conflict. Using revised subscales for Loss (7 items), Guilt (5 items), and Role Captivity (7 items), a total score for each subscale was calculated by summing numerical responses to the related questions. The scale ranges were: Loss (7-49), Guilt (5-35), Role Captivity (7-49). Each of the subscales (Sense of Loss, Guilt, and Role Captivity) were then summed to provide a Total score for FPCR, scores of which ranged from 19-133. For each of the subscales and the Total, higher scores represent more negative perceptions of the Caregiving Role, lower scores represent improved perceptions of the Caregiving Role. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CGMI-V Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Chronic Grief Management Intervention-Video: The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date. | 49 |
| Minimal Treatment (MT) Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline. | 48 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | administrative withdrawal | 1 | 1 |
Baseline characteristics
| Characteristic | CGMI-V | Minimal Treatment (MT) | Total |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 9.9 | 58.5 years STANDARD_DEVIATION 11.2 | 60.5 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 43 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marwit Meuser Caregiver Grief Inventory (MM-CGI) | 152.16 units on a scale STANDARD_DEVIATION 29.9 | 164.46 units on a scale STANDARD_DEVIATION 34.27 | 158.24 units on a scale STANDARD_DEVIATION 32.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 42 Participants | 33 Participants | 75 Participants |
| Region of Enrollment United States | 49 participants | 48 participants | 97 participants |
| Sex: Female, Male Female | 43 Participants | 43 Participants | 86 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 48 |
| other Total, other adverse events | 0 / 49 | 0 / 48 |
| serious Total, serious adverse events | 0 / 49 | 0 / 48 |
Outcome results
Primary
Marwit-Meuser Caregiver Grief Inventory (MM-CGI)
Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Population: Study data for 97 participants were analyzed, to determine the mean difference in CGMI-V scores from baseline to 24 weeks. The CGMI-V group was analyzed on an intent to treat (ITT) basis. At baseline, 49 participants were assigned to the CGMI-V group, of whom 44 provided data at Week 8 and 47 provided data at week 24. At baseline, 48 participants were assigned to the MT condition, of whom 45 provided data at Week 8 and 43 provided data at week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Marwit-Meuser Caregiver Grief Inventory (MM-CGI) | 12.75 units on a scale | Standard Deviation 9.01 |
| Minimal Treatment (MT) | Marwit-Meuser Caregiver Grief Inventory (MM-CGI) | 11.04 units on a scale | Standard Deviation 7.81 |
p-value: 0.001Regression, Linear
Secondary
Change in Anxiety Symptoms
State-Trait Anxiety Inventory (STAI) was used to represent anxiety symptoms. The (STAI) includes 20 questions, with responses based on a scale of 1 to 4 (1 = almost never to 4 = almost always). Numeric responses to these questions are summed to produce an inventory score, with a possible range of 20-80, where higher scores indicate greater anxiety, and lower scores indicate less anxiety.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Anxiety Symptoms | 5.77 units on a scale | Standard Deviation 4.08 |
| Minimal Treatment (MT) | Change in Anxiety Symptoms | 0.86 units on a scale | Standard Deviation 0.61 |
p-value: 0.001Regression, Linear
Secondary
Change in Conflict With Facility Staff
Conflict with facility staff was assessed with a subscale of 10 questions collected in the Family Perception of Caregiving Role (FPCR) tool. Scores on these 10 questions ranged from 1 (strongly disagree) to 7 (strongly agree). Response values associated with conflict subscale items were summed to produce total conflict scores ranging from 10-70. Lower scores indicate less conflict with facility staff, higher scores indicate more conflict with facility staff.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Conflict With Facility Staff | 3.83 units on a scale | Standard Deviation 2.71 |
| Minimal Treatment (MT) | Change in Conflict With Facility Staff | 3.75 units on a scale | Standard Deviation 2.65 |
p-value: 0.001Regression, Linear
Secondary
Change in Depressive Symptoms
Center for Epidemiological Studies Depression Scale (CES-D). The CES-D was assessed with 20-items, where responses are based on a four-point frequency rating (0 = rarely or none of the time to 3 = all of the time), with a possible range of 0 to 60. Larger scores represent more depressive symptoms, lower scores represent fewer symptoms.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Depressive Symptoms | 6.45 units on a scale | Standard Deviation 4.56 |
| Minimal Treatment (MT) | Change in Depressive Symptoms | 0.87 units on a scale | Standard Deviation 0.62 |
Comparison: Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).p-value: 0.001Regression, Linear
Secondary
Change in Positive States of Mind
Positive States of Mind Scale (PSOMS) was used to assess the extent to which caregivers were able to achieve six positive states of mind in the previous seven days. PSOM is based on 6 questions that are scored 0-4 and which are summed to produce scale scores that range from 0-24. Lower scores represent difficulty achieving positive states of mind in the past 7 days, higher scores indicate less difficulty achieving positive states of mind.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Positive States of Mind | 1.60 units on a scale | Standard Deviation 1.13 |
| Minimal Treatment (MT) | Change in Positive States of Mind | 0.11 units on a scale | Standard Deviation 0.08 |
p-value: 0.001Regression, Linear
Secondary
Change in Satisfaction With Care
The Family Perception of Care Tool (FPCT) is comprised of 51 questions with 7-point likert-type responses where 1=strongly agree and 7=strongly disagree. When summed to create a total FPCT score, values ranged from 51-357. Higher scores in the FPCT represent more positive feelings towards staff whereas lower scores represent more negative feelings.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Satisfaction With Care | 2.98 units on a scale | Standard Deviation 2.11 |
| Minimal Treatment (MT) | Change in Satisfaction With Care | 9.73 units on a scale | Standard Deviation 6.88 |
p-value: 0.001Regression, Linear
Other Pre-specified
Change in Caregiver Sense of Loss, Guilt, and Role Captivity
The Revised Family Perceptions of Caregiving Role (FPCR) instrument includes subscales for Loss, Guilt, Role Captivity, and Conflict. Using revised subscales for Loss (7 items), Guilt (5 items), and Role Captivity (7 items), a total score for each subscale was calculated by summing numerical responses to the related questions. The scale ranges were: Loss (7-49), Guilt (5-35), Role Captivity (7-49). Each of the subscales (Sense of Loss, Guilt, and Role Captivity) were then summed to provide a Total score for FPCR, scores of which ranged from 19-133. For each of the subscales and the Total, higher scores represent more negative perceptions of the Caregiving Role, lower scores represent improved perceptions of the Caregiving Role.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Caregiver Sense of Loss, Guilt, and Role Captivity | 3.84 units on a scale | Standard Deviation 2.72 |
| Minimal Treatment (MT) | Change in Caregiver Sense of Loss, Guilt, and Role Captivity | 4.58 units on a scale | Standard Deviation 3.24 |
Comparison: Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.p-value: 0.001Regression, Linear
Other Pre-specified
Change in Knowledge of Alzheimer's Disease
Family Knowledge of Alzheimer's Tool (FKAT) captures what a family caregiver knows about the disease process, how the care recipient is behaving, and how the long-term care facility (LTCF) is caring for him or her. Responses are based on a true/false scale, with scores ranging from 0 to 22 correct answers; larger scores indicate greater knowledge about AD, lower scores indicate less knowledge about AD.
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGMI-V | Change in Knowledge of Alzheimer's Disease | 0.29 units on a scale | Standard Deviation 0.21 |
| Minimal Treatment (MT) | Change in Knowledge of Alzheimer's Disease | 0.39 units on a scale | Standard Deviation 0.28 |
p-value: 0.001Regression, Linear