Alzheimer DiseaseNCT04103580
Caregiver Speaks: A Technologically Mediated Storytelling Intervention
A study testing Photo elicitation in people with Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Caregiver speaks is a randomized trial of a Photo elicitation intervention for caregivers of Alzheimers patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Photo elicitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be a designated family caregiver (i.e., a family member or friend providing unpaid care) of a PLWD who is enrolled in hospice care,
- be at least 18 years old,
- be involved in decisions related to their loved one's hospice care,
- have access to a digital camera or other photo-taking device such as a cell phone
- be willing to photograph images they feel capture their caregiving and bereavement experiences
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals With Alzheimer's Disease and Other Dementias
Caregiver speaks is a randomized trial of a Photo elicitation intervention for caregivers of Alzheimers patients.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Photo elicitation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo elicitationBehavioural
Caregivers are taught to use photos to illustrate various feelings and meanings
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Will receive usual hospice care plus measures |
| Intervention | Experimental | Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers Receives: Behavioral: Photo elicitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Mar 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 2 arm study; control and intervention
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Debra Parker Oliver, Washington University School of Medicine
- Investigators
- Debra Parker Oliver, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103580
- Sponsor's protocol ID
- 2016062 R01AG59818-01A1
- Status last verified
- Feb 2025
- First submitted
- 25 Jul 2019
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared
Publications
Rolbiecki AJ, Pitzer K, Benson JJ, Washington KT, Teti M, Kruse RL, Mehr DR, Smith J, Oliver D. Caregiver speaks: a randomized controlled trial of a storytelling intervention for hospice family caregivers of persons with dementia. Gerontologist. 2026 Jun 9;66(7):gnag117. doi: 10.1093/geront/gnag117.
PubMed 42185076
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals With Alzheimer's Disease and Other Dementias
- ClinicalTrials.gov ID
- NCT04103580
- Acronym / sponsor ID
- 2016062 R01AG59818-01A1
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 2 arm study; control and intervention
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Will receive usual hospice care plus measures |
| Intervention | Experimental | Behavioral: Photo elicitationWill receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be a designated family caregiver (i.e., a family member or friend providing unpaid care) of a PLWD who is enrolled in hospice care,
- be at least 18 years old,
- be involved in decisions related to their loved one's hospice care,
- have access to a digital camera or other photo-taking device such as a cell phone
- be willing to photograph images they feel capture their caregiving and bereavement experiences
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Photo elicitationCaregivers are taught to use photos to illustrate various feelings and meanings | Behavioural | Intervention |
Primary outcome
Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score
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.
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
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42185076Rolbiecki AJ, Pitzer K, Benson JJ, Washington KT, Teti M, Kruse RL, Mehr DR, Smith J, Oliver D. Caregiver speaks: a randomized controlled trial of a storytelling intervention for hospice family caregivers of persons with dementia. Gerontologist. 2026 Jun 9;66(7):gnag117. doi: 10.1093/geront/gnag117.
- Individual participant dataSharing planned: No. No individual data will be shared
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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.
Debra Parker Oliver, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo elicitation in people with Alzheimer Disease, run by Washington University School of Medicine 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 6 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 26 Feb 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score (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.). The study lists 2 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 NCT04103580, 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 26 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.