Alzheimer Disease
Conditions
Brief summary
Caregiver speaks is a randomized trial of a Photo elicitation intervention for caregivers of Alzheimers patients.
Detailed description
This randomized controlled trial will test an intervention for an understudied population - family caregivers of persons living with dementia (PLWD). This project is the first of its kind to longitudinally follow family caregivers of PLWD into bereavement. Furthermore, the intervention, Caregiver Speaks, employs an innovative storytelling approach - photo elicitation (the use of photos to elicit thoughts, feelings, and reactions to a person's experience) - to encourage family caregivers to make meaning of their caregiving and bereavement experiences as a way of reducing depression, anxiety, and ultimately grief intensity. Caregiver Speaks is deployed via a readily available social media network (Facebook), which allows easy access for already overburdened family caregivers of PLWD, and can improve their social support. Preliminary work demonstrates that 1) this project is feasible as an RCT intervention study of caregiver experiences, 2) the research team can conduct this type of storytelling intervention via Facebook, and 3) family caregivers use (and want to use) social media during active caregiving and into bereavement, despite their heavy care burdens. The research team will base the proposal on Park and Folkman's meaning-making model of stress and coping. This model illustrates how individuals cope with adverse life events (i.e., trauma, or death of a loved one) by reconstructing and transforming the event's meaning and incorporating the reappraised meaning into one's larger self-narrative. Caregiver Speaks uses storytelling in the form of photo-elicitation, in order to facilitate this meaning-making. Caregivers share photos and discussions regarding their caregiving and bereavement experiences in a private, facilitated Facebook group. This model suggests that caregivers' ability to make sense of (meaning making), and find benefit in an adverse life situation (caregiving and bereavement) will be validated through social support, and result in reduced depression, anxiety, and grief intensity. Caregivers will be randomly assigned to either: 1) Group 1, which will receive the Caregiver Speaks intervention, or 2) Group 2, which will receive standard care, including the standard care for bereavement. The research team will use both quantitative and qualitative methods in parallel and equal status to measure the intervention's efficacy. The overall hypothesis is that participating in Caregiver Speaks during caregiving and into bereavement will reduce caregivers' depression and anxiety, and as a result will reduce grief intensity in bereavement. The three specific aims are to: 1) determine the efficacy of the Caregiver Speaks intervention in reducing depression and anxiety among family caregivers of people with dementia, 2) examine the intervention's effect on grief intensity among bereaved family caregivers of people with dementia, and 3) describe how caregivers made meaning of their caregiving and bereavement experiences.
Interventions
BEHAVIORALPhoto elicitation
Caregivers are taught to use photos to illustrate various feelings and meanings
Sponsors
University of Pennsylvania
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized 2 arm study; control and intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. be a designated family caregiver (i.e., a family member or friend providing unpaid care) of a PLWD who is enrolled in hospice care, 2. be at least 18 years old, 3. be involved in decisions related to their loved one's hospice care, 4. have access to a digital camera or other photo-taking device such as a cell phone 5. be willing to photograph images they feel capture their caregiving and bereavement experiences 6. be willing to set up a Facebook account and join the private Facebook group, 7) have access to e-mail for REDCap survey data collection
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score | Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup. | Caregiver anxiety measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more anxiety. |
| Patient Health Questionnaire-9 (PHQ-9) Depression Score | Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup. | Caregiver depression measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more depression. |
Countries
United States
Participant flow
Pre-assignment details
Enrollment considered complete and random assignment made only after the baseline survey was completed. The baseline analysis population excludes those who were not truly randomized. Some participants who cared for the same patient were assigned to the same group (without any randomization) as the first participant from that cohort who was truly randomized. These are recorded as Not truly randomized as a category of participants under Incomplete in each phase.
Participants by arm
| Arm | Count |
|---|---|
| Control Will receive usual hospice care plus measures | 214 |
| Intervention Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers
Photo elicitation: Caregivers are taught to use photos to illustrate various feelings and meanings | 211 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 Active Caregiving | Care Recipient Died before First Follow-up | 41 | 35 |
| Phase 1 Active Caregiving | Decertified from Hospice | 3 | 1 |
| Phase 1 Active Caregiving | Lost to Follow-up | 18 | 45 |
| Phase 1 Active Caregiving | Not truly randomized (cohort-randomized with other family caregivers) | 13 | 19 |
| Phase 1 Active Caregiving | Other | 3 | 3 |
| Phase 1 Active Caregiving | Withdrawal by Subject | 5 | 14 |
| Phase 2 Bereavement | Lost to Follow-up | 2 | 6 |
| Phase 2 Bereavement | Not truly randomized (cohort-randomized with other family caregivers) | 6 | 7 |
| Phase 2 Bereavement | Other | 8 | 6 |
| Phase 2 Bereavement | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 11 | 60.5 years STANDARD_DEVIATION 10.4 | 60.7 years STANDARD_DEVIATION 9.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 12 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants | 403 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 10 Participants | 6 Participants |
| GAD-7 | 8.33 units on a scale STANDARD_DEVIATION 5.92 | 8.37 units on a scale STANDARD_DEVIATION 5.61 | 8.41 units on a scale STANDARD_DEVIATION 5.29 |
| PHQ-9 | 7.20 units on a scale STANDARD_DEVIATION 6.39 | 7.25 units on a scale STANDARD_DEVIATION 6.01 | 7.31 units on a scale STANDARD_DEVIATION 5.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 75 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) White | 166 Participants | 328 Participants | 162 Participants |
| Sex/Gender, Customized Sex Female | 176 Participants | 350 Participants | 174 Participants |
| Sex/Gender, Customized Sex Male | 36 Participants | 73 Participants | 37 Participants |
| Sex/Gender, Customized Sex Other | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Sex Unknown | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 227 | 0 / 230 |
| other Total, other adverse events | 0 / 227 | 0 / 230 |
| serious Total, serious adverse events | 0 / 227 | 0 / 230 |
Outcome results
Primary
Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score
Caregiver anxiety measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more anxiety.
Time frame: Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup.
Population: Each analysis population includes participants that had at least one follow-up after first measure in each phase.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control - Phase 1 | Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score | -0.014 score on a scale change per day | Standard Error 0.003 |
| Intervention - Phase 1 | Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score | -0.008 score on a scale change per day | Standard Error 0.004 |
| Control - Phase 2 | Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score | -0.005 score on a scale change per day | Standard Error 0.002 |
| Intervention - Phase 2 | Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score | -0.013 score on a scale change per day | Standard Error 0.003 |
Comparison: The null hypothesis is that there is no difference between control and intervention over time in Phase 1.p-value: 0.247Mixed Models Analysis
Comparison: The null hypothesis is that there is no difference between control and intervention over time in Phase 2.p-value: 0.049Mixed Models Analysis
Primary
Patient Health Questionnaire-9 (PHQ-9) Depression Score
Caregiver depression measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more depression.
Time frame: Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup.
Population: Each analysis population includes participants that had at least one follow-up after first measure in each phase.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control - Phase 1 | Patient Health Questionnaire-9 (PHQ-9) Depression Score | -0.007 score on a scale change per day | Standard Error 0.003 |
| Intervention - Phase 1 | Patient Health Questionnaire-9 (PHQ-9) Depression Score | -0.001 score on a scale change per day | Standard Error 0.003 |
| Control - Phase 2 | Patient Health Questionnaire-9 (PHQ-9) Depression Score | -0.011 score on a scale change per day | Standard Error 0.002 |
| Intervention - Phase 2 | Patient Health Questionnaire-9 (PHQ-9) Depression Score | -0.013 score on a scale change per day | Standard Error 0.003 |
Comparison: The null hypothesis is that there is no difference between control and intervention over time in Phase 1.p-value: 0.15Mixed Models Analysis
Comparison: The null hypothesis is that there is no difference between control and intervention over time in Phase 2.p-value: 0.635Mixed Models Analysis