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Caregiver Speaks: A Technologically Mediated Storytelling Intervention

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ClinicalTrials.gov Identifier: NCT04103580
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : May 18, 2022
Information provided by (Responsible Party):
Debra Parker Oliver, Washington University School of Medicine

Brief Summary:
Caregiver speaks is a randomized trial of a Photo elicitation intervention for caregivers of Alzheimers patients.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Photo elicitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 2 arm study; control and intervention
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals With Alzheimer's Disease and Other Dementias
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
No Intervention: Control
Will receive usual hospice care plus measures
Experimental: Intervention
Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers
Behavioral: Photo elicitation
Caregivers are taught to use photos to illustrate various feelings and meanings

Primary Outcome Measures :
  1. Change in Public Health Questionaire- 9 depression score [ Time Frame: Baseline and twelve months ]
    Caregiver depression measure.Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higer scores indicate more depression.

Secondary Outcome Measures :
  1. Change in General Anxiety Disorder -7 anxiety score [ Time Frame: Baseline and twelve months ]
    Caregiver anxietyResponse options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Total scores of 5, 10, and 15 represent thresholds for mild, moderate, and severe anxiety, respectively. Total scores of 10 or higher are generally considered clinically significant, signaling a need for additional evaluation and possible intervention

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103580

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Contact: Debra Parker Oliver, PhD 573-356-6719 oliverd@wustl.edu
Contact: Abigail Rolbeicki, PhD 214-500-7639 "Rolbiecki, Abigail J." <RolbieckiA@health.missouri.edu>

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United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65202
Contact: Abigail Rolbiecki, PhD       Rolbieckia@missouri.edu   
Contact: Christi Lero, MSW       leroc@missouri.edu   
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Debra Parker Oliver, PhD Washington University School of Medicine
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Responsible Party: Debra Parker Oliver, Professor, Division of Palliative Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04103580    
Other Study ID Numbers: 2016062 R01AG59818-01A1
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders