Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058886
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Alzheimer Dementia Caregiver Dementia Alzheimers Behavioral: Telephone-delivered Mindfulness Not Applicable

Detailed Description:

Mindfulness interventions can decrease caregiver burden and improve coping skills, including decreased emotion-based coping, increased tolerance for uncertainty, improved psychological well-being and quality of life while potentially improving relationship quality and communication.

This study utilizes a single-group, uncontrolled design to assess 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 telephone-delivered mindfulness intervention will improve geographical access for rural caregivers and deem more flexible for a caregiver's schedule. The study's intervention consists of mindfulness training delivered by telephone once weekly for 8 weeks. The intervention also includes one in-person 3.5-hour retreat for which respite care will be provided. The intervention, based on, Kabat-Zinn's mindfulness-based stress reduction (MBSR), will emphasize the following: 1) mindful experiencing, including mindfulness of feelings and body sensations; 2) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and 3) mindful compassion for self and others.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Telephone-delivered Mindfulness
Participating caregivers and care partners will receive mindfulness training in 8 weekly telephone sessions plus one 3.5-hour retreat. Respite care for the care recipient is provided for the retreat.
Behavioral: Telephone-delivered Mindfulness
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).




Primary Outcome Measures :
  1. Number of telephone sessions attended [ Time Frame: 8 weeks ]
    The instructor will conduct a role call to take attendance at the beginning of each of the 8 class sessions. Attending 6 out of 9 sessions signifies intervention acceptability. Attendance used as a proxy to assess intervention acceptability.

  2. Total number of individuals screened for enrollment [ Time Frame: Pre-intervention ]
    The total number of participants screened for eligibility will be used as a proxy to assess recruitment feasibility in this geographic area.

  3. Proportion of screened individuals who qualify for enrollment [ Time Frame: Pre-intervention ]
    Proportion measured by the number of eligible individuals screened for enrollment divided by the total number of individuals screened for enrollment. This is used as a proxy to assess recruitment feasibility in this geographic area.

  4. Number of qualifiers who enroll [ Time Frame: Pre-intervention ]
    The number of eligible individuals who enroll in the study will be divided by the total number of eligible individuals screened. Recruitment feasibility will be reached if 75% of the total number of eligible individuals screened enroll into the study. This is used as proxy to assess study feasibility.

  5. Number enrolled who complete the intervention [ Time Frame: 8 weeks ]
    The number of participants enrolled who complete the intervention. Feasibility will be reached if 80% of those enrolled complete the intervention. This is used as a proxy to assess recruitment feasibility.

  6. Total number of Interviews completed with intervention participants [ Time Frame: 8 weeks ]
    The total number of interviews completed with those who participated in the intervention will be used to assess adherence and feedback about the study protocol. A study-specific interview guide will be used to conduct interviews with participants who complete the intervention and who dropout of the intervention. Interviews will collect information about the timing of sessions, satisfaction with intervention format, components fostering engagement in intervention group/materials, and factors leading to dropout, where applicable. A study-specific tracking sheet will be used to note the total number of interviews completed. This is used as a proxy to assess adherence to the study protocol.

  7. Total number of audio recordings of intervention sessions [ Time Frame: 8 weeks ]
    The total number of audio recordings of intervention sessions will be used to asses program fidelity. Each intervention session will be audio recorded to identify any systematic variations in instructor attitude, instructor communication, behavior between groups, group-dependent differences in content/style between instructor/participants, and participant input during sessions. This is used as a proxy to assess program fidelity.


Secondary Outcome Measures :
  1. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Emotional Distress-Anxiety-Short Form 4a is a 4-item scale that assesses fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). It uses a 5-point Likert scale (1=never to 5=always). Raw scores range from 4-20 with lower scores representing less endorsement of anxiety. This item will be administered at baseline and 8 weeks.

  2. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anger-Short Form 5a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Emotional Distress-Anger-Short Form 5a item is a 5-item scale that assesses angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. It uses a 5-point Likert scale (1=never to 5=always). Raw scores range from 5-25 with lower scores reflecting less endorsement of anger. This scale will be administered at baseline at 8 weeks.

  3. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose-Short Form 6a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Meaning and Purpose-Short Form 6a is a 6-item scale that assesses a sense that life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. It is a reliable, validated, population-normed well-being measure developed to assess positive emotions. It uses a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Raw scores range from 6-30 with higher scores representing more endorsement of meaning and life.This item will be administered at baseline and 8 weeks.

  4. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health [ Time Frame: baseline, 8 weeks ]
    The PROMIS Global Physical Health is a 2-item scale that assesses overall evaluation of one's physical health. It is based on the well-validated Rand measure, assessing general self-rated physical health, physical function, pain, and fatigue. It has a marginal reliability of 0.81. It uses a 5-point Likert scale (1=poor to 5=excellent). Raw scores range from 2-10 with higher scores representing more endorsement of good physical health. PROMIS Global Physical Health will be administered at baseline and 8 weeks.

  5. Change from baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form [ Time Frame: baseline, 8 weeks ]
    Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form is an 18-item measure consisting of 5 positive coping strategies (acceptance, positive refocusing, planning, positive reappraisal, putting into perspective) and 4 negative strategies (rumination, catastrophizing, self-blame, other-blame). Subscale reliability (α=0.68-0.81) and convergent validity was good. Items are measured on a 5-point Likert scale (1=(almost) never to 5=(almost) always). Total scores range from 18-90 with higher scores representing more cognitive emotional regulation and higher subscale scores represent more of a specific strategy being used. The CERQ will be administered at baseline and at 8 weeks.

  6. Change from baseline on Intolerance of Uncertainty Scale (IUS-12) [ Time Frame: baseline, 8 weeks ]
    Intolerance of Uncertainty Scale (IUS-12) is a 12 item measure consisting of 2 factors: prospective anxiety (7 items) and inhibitory anxiety ( 5 items). It correlates highly (0.96) with the original 27-item scale. Its reliability was high for both the overall score (ρ=0.92) and factors. It demonstrated convergent validity. The measure uses a 5-point Likert scale (1=not at all like me to 5=entirely like me). Total scores range from 12-60, with lower scores reflecting more tolerance of uncertain situations. IUS-12 will be administered at baseline and at 8 weeks.

  7. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Emotional Support-Short Form 4a is a 4-item scale that assesses perceived feelings of being cared for and valued as a person and having confidant relationships. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20 with higher scores reflecting more positive endorsement of emotional support. PROMIS Emotional Support item will be administered at baseline and 8 weeks.

  8. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Informational Support-Short Form 4a is a 4-item scale that assesses perceived availability of helpful information or advice. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20 with higher scores reflecting more positive endorsement of informational support. This item will be administered at baseline and 8 weeks.

  9. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Instrumental Support-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Instrumental Support-Short Form 4a is a 4-item scale that assesses perceived availability of assistance with material, cognitive or task performance. Item responses use a 5-point LIkert scale (1=never to 5=always). Raw scores range from 4-20 with higher scores reflecting more positive endorsement of instrumental support. This item will be administered at baseline and 8 weeks.

  10. Change from baseline on Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [ Time Frame: baseline, 8 weeks ]
    The CAMS-R is a 12-item scale measuring mindfulness by using language that is not representative of any particular meditation training or practice. It uses a 4-point Likert scale with responses ranging from 1 (Rarely/Not at all) to 4 (Almost always). Total scores range from 12-48. Higher scores indicate higher levels of mindfulness. CAMS-R will be administered at baseline and 8 weeks.

  11. Change from baseline on Family Satisfaction Scale (FSS) [ Time Frame: baseline, 8 weeks ]
    The FSS is a 10-item scale has test retest reliability of 0.85 and alpha of 0.92. Convergent validity demonstrated in survivors of traumatic brain injury. Mean in sample of 2,465 = 37.5 with a standard deviation of 8.5. The measure uses a 5-point Likert scale (1=very dissatisfied to 5=extremely satisfied). Total scores range from 10-50 with higher scores representing more endorsement of family satisfaction. FSS will be administered at baseline and 8 weeks.

  12. Change from baseline on Family Conflict Scale (FCS) [ Time Frame: baseline, 8 weeks ]
    The FCS is a 12 item scale that measures the degree of conflict the family experiences about the seriousness of the care recipient's condition, concerns about the care recipient's safety, what the care recipient can do for him/herself, and whether a nursing home is indicated. It has the 3 subscales: 1) conflict around definitions of the illness and strategies for care (4 items), 2) conflict around family members' attitudes and action toward the patient (4 items), and 3) conflict around family members' actions and attitudes around the caregiver (4 items). Items are measured on a 4-point Likert scale (1=no disagreement to 4=quite a bit of disagreement). The total scores range from 12-48 with lower scores representing less family conflict. FCS will be administered at baseline and 8 weeks.

  13. Change from baseline on Zarit Burden Interview Short Form (ZBI-12) [ Time Frame: baseline, 8 weeks ]
    The ZBI-12 is a 12-item (SF) version of the original 29-item questionnaire measures role strain (α=0.88) and personal strain (α=0.77). The short form was highly correlated with the original (0.96) both at baseline and follow-up. Items are measured on a 5-point Likert scale (0=never to 4=nearly always). Scores range from 0-48 with lower scores representing less burden. ZBI will be administered at baseline and 8 weeks.

  14. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    PROMIS General Self-Efficacy-Short Form 4a is a 4-item scale that assesses confidence in ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Items are measured on a 5-point Likert scale (1=I am not at all confident to 5=I am very confident). Raw scores range from 4-20 with higher scores representing more confidence. This measure will be administered at baseline and 8 weeks.

  15. Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Emotions-Short Form 4a [ Time Frame: baseline, 8 weeks ]
    The PROMIS Self-Efficacy for Managing Emotions-Short Form 4a is a 4-item scale that assesses confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger. Items are measured using a 5-point Likert scale (1=I am not at all confident to 5=I am very confident). Raw scores range from 4-20 with higher scores indicating more confidence with managing emotion. This measure will be administered at baseline and 8 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 a score of at least 5 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 candidate has participated in prior mindfulness training;
  • The candidate reports a history of serious mental illness (i.e., psychosis) requiring more than two psychotropic medications per day or hospitalization for a psychiatric condition;
  • The candidate reports a current substance use disorder that causes disability or family conflict.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058886


Contacts
Layout table for location contacts
Contact: Chanee Lynch, MPH 919-966-8586 chanee_lynch@med.unc.edu
Contact: Keturah Faurot, PA, MPH, PhD 919-357-7235 faurot@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
UNC Program on Integrative Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7200
Contact: Chanee Lynch, MPH    919-966-8586    chanee_lynch@med.unc.edu   
Principal Investigator: Susan Gaylord, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Susan Gaylord, PhD UNC-Chapel Hill
Principal Investigator: Sharon Williams, PhD UNC Chapel Hill
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04058886    
Other Study ID Numbers: 19-0053
R21AG061728 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 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 the University of North Carolina at Chapel Hill (UNC).
Supporting Materials: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases