Supporting Family Caregivers of Persons With Dementia

NCT05336344 | Completed

• 1 other identifier: 849217
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).

Conditions

Depression; Caregiver Stress Syndrome; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Quality of Life-Index (CQLI-R) scores

  The CQLI-R, a four-item measure of caregivers' quality of life (QOL), includes four dimensions: emotional, social, financial, and physical. Total score ranges from 0 to 40 (higher score indicates higher quality of life).

  assessments at week 1, week 3 and 40 day follow-up

Secondary Outcomes (3)

• Change in Generalized Anxiety Disorder (GAD-7) for caregivers

  assessments at week 1, week 3 and 40 day follow-up

• Change in the Depression Scale of the Patient Health Questionnaire (PHQ-9)

  assessments at week 1, week 3 and 40 day follow-up

• Change in the Pain Assessment in Advanced Dementia (PAINAD) Scale score

  assessments at week 1, week2, week 3 and 40 day follow-up

Study Arms (2)

ENCODE Group

EXPERIMENTAL

The intervention consists of three weekly video-conferencing sessions scheduled at the caregiver's convenience. Each session is scheduled to last approximately 40 minutes. The ENCODE intervention is manualized and has related curriculum designed specifically for caregivers of patients with ADRD. The agenda for the first session (week 1) includes an assessment of caregivers' pain management challenges and concerns. Once the barriers or challenges are identified, the interventionist works specific problem solving therapy steps covered over the three sessions.

Behavioral: ENCODE

Attention Control Group

NO INTERVENTION

Caregivers in the attention control group will receive standard hospice services and complete the same measures and receive the same number of contacts as participants in the intervention group. Three video-conferencing calls will be scheduled based on the caregiver's availability following, if possible, a timeline between days 5 and 30 of the hospice admission. During these calls, the interventionist will allow caregivers in the attention control group to discuss their feelings, thoughts, and relationships. This "friendly call" intervention controls for the nonspecific aspects of treatment, i.e., the passage of time, amount of contact with a researcher, and the general support of an empathic, concerned and skilled professional and is based on the principles of nondirective supportive therapy.

Interventions

ENCODE BEHAVIORAL

a cognitive behavioral intervention for family caregivers to improve pain management skills and overall coping

ENCODE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled as a family/informal caregiver of a hospice patient with primary or secondary diagnosis of Alzheimer's disease or other related dementia
• responding with "yes" to the question about having any concerns about effectively managing their care recipient's pain
• years or older
• no or only mild cognitive impairment
• speak and read English, with at least a 6th-grade education

You may not qualify if:

• Significant hearing loss that does not allow the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Clinical Coding

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Forms and Records Control; Office Management; Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Medical Records; Records; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Methods; Public Health; Environment and Public Health

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: PIK University Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 20, 2022
• Study Start: July 15, 2022
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)