Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)

NCT04603482 | Completed Results DMC

• 1 other identifier: R01NR018476
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).

Conditions

Stress; Carer Stress Syndrome; Dementia; Alzheimer's Disease; Bereavement

Keywords

Caregiver; Biofeedback; Resourcefulness; Self-Management

Outcome Measures

Primary Outcomes (6)

• Change in Caregiver's Perceived Stress Scale

  14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress

  From T1 (baseline) to T2 (6 months) through T3 (one year)

• Change in Caregiver's Negative Emotions Checklist

  10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.

  From T1 (baseline) to T2 (6 months) through T3 (one year)

• Change in Caregiver's Depressive Cognitions Scales

  8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition

  From T1 (baseline) to T2 (6 months) through T3 (one year)

• Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)

  Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.

  From T1 (baseline) to T2 (6 months) through T3 (one year)

• Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)

  Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.

  From T1 (baseline) to T2 (6 months) through T3 (one year)

• Change in Caregiver's Health Risk Behavior Scale

  Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk

  From T1 (baseline) to T2 (6 months) through T3 (one year)

Study Arms (3)

Self-management intervention based on Need

ACTIVE COMPARATOR

Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to baseline data.

Behavioral: Resourcefulness training; Behavioral: Biofeedback

Self-management intervention based on Preference

ACTIVE COMPARATOR

Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to their preference.

Behavioral: Resourcefulness training; Behavioral: Biofeedback

Attention Control: Diversonal Activities

PLACEBO COMPARATOR

Participants randomly assigned to this arm will be presented with diversional activities.

Behavioral: Attention Control

Interventions

Resourcefulness training BEHAVIORAL

Resourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity.

Self-management intervention based on Need; Self-management intervention based on Preference

Biofeedback BEHAVIORAL

Biofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation.

Self-management intervention based on Need; Self-management intervention based on Preference

Attention Control BEHAVIORAL

Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format.

Attention Control: Diversonal Activities

Eligibility Criteria

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

You may qualify if:

• At least 18 years old
• Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia
• Identify self as a primary caregiver
• In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
• Be capable of performing informed consent and participating in study procedures

You may not qualify if:

• Does not have a family member with Alzheimer's disease or another dementia
• Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months
• Has knowledge of another family member in the same household enrolled in the study
• Currently pregnant
• Has a pacemaker
• Lives outside of the study area

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

CWRU School of Nursing

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Results Point of Contact

• Title: Jaclene Zauszniewski, PhD
• Organization: Case Western Reserve University

jaz@case.edu

216.368.3612

Study Officials

• Jaclene A Zauszniewski, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were aware of which intervention they were receiving (Resourcefulness Training, HRV-focused BioFeedback, Attention Control: Diversonal Activities, but were not aware of which arm they had been randomly assigned to, or whether their intervention was an active or placebo comparator. The PI and Outcomes Assessor were blinded as to the identity of individual participants, and, during data collection, which participants had been assigned to which arm/intervention. In order to complete study aims, variables indicating arm and intervention assignment were included in the final data file.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: January 8, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 13, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-05

Locations

US (1)