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N/A N=57 Other

Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers

Alzheimer Dementia · Caregiver · Dementia Alzheimers

Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Participants Attending at Least 6 Telephone Sessions — 27; 23; 50 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Telephone-delivered Mindfulness (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Attending at Least 6 Telephone Sessions
27; 23; 50
PRIMARY
Percent of Dyads Who Endorse the Program
100
SECONDARY
Change From Baseline in the Zarit Burden Interview Short Form (ZBI-12) Score
-2.5; -3.6; -2.9
SECONDARY
Change From Baseline in the Family Satisfaction Scale (FSS) Score
2.78; 4.30; 3.12
SECONDARY
Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Prospective Subscale Score
-1.11; -1.00; -1.16
SECONDARY
Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Inhibitory Subscale Score
-0.81; -1.17; -0.97
SECONDARY
Change From Baseline on PROMIS Meaning and Purpose-Short Form 6a
3.18; 2.23; 2.7
SECONDARY
Change From Baseline on Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
2.77; 2.04; 2.5
SECONDARY
Change From Baseline on PROMIS Emotional Distress-Anxiety-Short Form 4a
-0.9; 0.06; 0.67
SECONDARY
Change From Baseline on PROMIS Emotional Distress-Anger-Short Form 5a
-0.79; 2.21; 0.67
SECONDARY
Change From Baseline on PROMIS Global Physical Health
-1.85; -1.16; -1.45
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form
1.48; 0.88; 1.29
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Acceptance)
0.07; -0.46; -0.22
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Refocusing)
0.15; 1.08; 0.55
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Planning)
0.15; -0.57; -0.21
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Reappraisal)
0.07; 0.25; 0.25
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Putting Into Perspective)
-0.41; 0.67; 0.23
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Rumination)
-1.0; -0.04; -0.49
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Catastrophizing)
-0.37; -0.13; -0.30
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Self-Blame)
-0.52; 0.08; -0.30
SECONDARY
Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Other-Blame)
0.11; 0.21; 0.14
SECONDARY
Change From Baseline on PROMIS Emotional Support-Short Form 4a
0.48; 1.39; 0.89
SECONDARY
Change From Baseline on PROMIS Informational Support-Short Form 4a
2.72; 2.05; 2.65
SECONDARY
Change From Baseline on PROMIS Instrumental Support-Short Form 4a
0.87; 0.35; 0.65
SECONDARY
Change From Baseline on PROMIS General Self-Efficacy-Short Form 4a
2.51; 1.79; 2.2
SECONDARY
Change From Baseline in Mean NPI-Q Distress Scores
-2.31; -1.24; -1.8
SECONDARY
Change From Baseline on PROMIS Self-Efficacy for Managing Emotions-Short Form 4a
1.96; -0.06; 0.98
SECONDARY
Change From Baseline in the Family Conflict Strategies for Care Subscale
-0.30; -0.17; -0.23
SECONDARY
Change From Baseline in the Family Conflict Scale Attitudes and Actions Toward the Patient Subscale
-0.30; -0.43; -0.34
SECONDARY
Change From Baseline on Family Conflict Scale (FCS) Actions and Attitudes Toward the Caregiver Subscale
-0.06

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04058886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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