Caregiver Speaks: A Technologically Mediated Storytelling Intervention

NCT04103580 | Completed Results

• 1 other identifier: 2016062 R01AG59818-01A1
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (2)

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

Behavioral: Photo elicitation

Interventions

Photo elicitation BEHAVIORAL

Caregivers are taught to use photos to illustrate various feelings and meanings

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65202, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Kyle Pitzer: Study Statistical Data Analyst
• Organization: Washington University

kyleapitzer@wustl.edu

314-747-5361

Study Officials

• Debra Parker Oliver, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Palliative Medicine

Model Details: Randomized 2 arm study; control and intervention

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: September 25, 2019
• Study Start: March 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)