Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers

NCT04058886 | Completed Results DMC

• 2 other identifiers: 19-0053R21AG061728
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is assesses the feasibility and acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden for African-American rural caregivers of individuals with moderate to severe dementia, as defined by the caregiver. The study utilizes a single-group, uncontrolled design to test the feasibility and acceptability of the intervention for the target population.

Conditions

Alzheimer Dementia; Caregiver; Dementia Alzheimers

Outcome Measures

Primary Outcomes (2)

• Number of Participants Attending at Least 6 Telephone Sessions

  The instructor will conduct a role call to take attendance at the beginning of each of the 8 class sessions and 1 retreat session. Eighty-five percent of participants who start the intervention will complete at least 6 out of 9 intervention sessions. Attendance used as a proxy to assess intervention acceptability.

  8 weeks

• Percent of Dyads Who Endorse the Program

  The intervention will be acceptable to informal caregiving teams as evidenced by an 85 percent (95% Confidence Interval (CI): 72.5, 97.5) endorsement of the program in post-participation interviews. Calculated based on responses to open-ended questions regarding participants' experiences of the intervention. Examples of questions are: "how valuable or beneficial was the mindfulness training to you?" and "what challenges did you have with the training?" and "what did you expect from the training that you did not get?". Endorsement was considered positive if the expressions of value outweighed challenges (i.e., positive comments outweighed negative comments by dyad). Data reported as caregiving teams (dyads) in accordance with the protocol.

  8 weeks

Secondary Outcomes (28)

• Change From Baseline in the Zarit Burden Interview Short Form (ZBI-12) Score

  Baseline, 8 weeks

• Change From Baseline in the Family Satisfaction Scale (FSS) Score

  up to 8 weeks

• Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Prospective Subscale Score

  up to 8 weeks

• Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Inhibitory Subscale Score

  up to 8 weeks

• Change From Baseline on PROMIS Meaning and Purpose-Short Form 6a

  Baseline, 8 weeks

Study Arms (1)

Telephone-delivered Mindfulness

EXPERIMENTAL

Participating caregivers and care partners will receive mindfulness training in 8 weekly telephone sessions plus one retreat. Respite care for the care recipient is provided for the retreat.

Behavioral: Telephone-delivered Mindfulness

Interventions

Telephone-delivered Mindfulness BEHAVIORAL

The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified MBSR program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g. mindful eating, and mindful listening).

Telephone-delivered Mindfulness

Eligibility Criteria

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

You may qualify if:

• The candidate is at least 18 years old;
• The candidate self-identifies as Black or African American;
• The candidate provides at least 4 hours of care per day to the care recipient, who must have either a diagnosis of dementia OR have a score of at least 2 or higher on the Alzheimer's Disease Screening tool (AD-8) or a score of 8 or higher on the Functional Assessment Staging of Alzheimer's disease (FAST) scale (indicative of moderate - severe dementia);
• The candidate is able to identify and recruit an additional informal caregiver (care partner) to participate in the study. The care partner must consider themselves as part of the caregiving team that helps to make decisions about the care of the care recipient. The care partner may be a blood relative or close friend, but not a formal caregiver. The care partner need not live in the same geographic area.
• Both the candidate primary caregiver and care partner must have access to a telephone and express a willingness to participate in the pre- and post-participation assessments, the intervention calls, and the intervention retreat.

You may not qualify if:

• The candidate is too unwell to participate; e.g., with an active diagnosis of cancer or more than 3 hospitalizations in the past year;
• The primary caregiver is unable to identify and recruit a care partner willing to commit to the study requirements;
• The care recipient does not meet the criteria for dementia.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UNC Program on Integrative Medicine

Chapel Hill, North Carolina, 27599-7200, United States

Location

Related Publications (1)

• Faurot KR, Roth I, Harr E, Shafer J, Giscombe K, Sheffield-Abdullah KM, Lathren C, Brantley M, Williams SW, Gaylord SA. Feasibility of a Telephone-Delivered Mindfulness Intervention for Informal Caregivers of Rural-Dwelling African Americans With Dementia. Glob Adv Integr Med Health. 2025 Jun 4;14:27536130251347944. doi: 10.1177/27536130251347944. eCollection 2025 Jan-Dec.

  PMID: 40475373 DERIVED

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: Kim Faurot, PhD
• Organization: University of North Carolina at Chapel Hill

faurot@med.unc.edu

919-966-8586

Study Officials

• Susan Gaylord, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Sharon Williams, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: November 15, 2019
• Primary Completion: July 4, 2022
• Study Completion: July 6, 2022
• Last Updated: July 19, 2023
• Results First Posted: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)