NCT04346745

Brief Summary

Although many older Chinese Americans are expected to need intensive care because of cognitive impairment, a large gap exists in development of culturally sensitive interventions to reduce stress among caregivers in Chinese American communities. This research project will develop and pilot test a culturally sensitive intervention, the peer mentoring program (PMP), which is informed by the sociocultural stress and coping model. This project will generate preliminary data for a larger randomized controlled trial for efficacy or effectiveness testing of PMP, which is an innovative intervention to support dementia among Chinese Americans, by empowering the existing human resources of experiential caregivers in the same ethnic community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

April 8, 2020

Results QC Date

April 10, 2023

Last Update Submit

August 19, 2024

Conditions

Keywords

ChineseVolunteeringPeer mentoringdementia caregiversmental healthstress

Outcome Measures

Primary Outcomes (4)

  • Caregiver Burden Score at Month 3 and Month 9

    This outcome will be measured by Zarit's Burden Interview (ZBI). ZBI contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). In general, higher score indicates higher levels of burden. The full summed score ranges from 0 to 88, with higher scores indicating higher levels of burden (Cronbach's α = .80).

    Month 3, Month 9

  • Caregiver's Depression at Month 3 and Month 9

    Depressive symptoms were measured by the 10-item Center for Epidemiological Studies Depression Scale (Andresen et al., 1994). Caregivers reported their depressive symptoms in the past week on a 4-point scale (from 0 = rarely or none of the time to 3 = most or all of the time). The summed scores ranged from 0 to 30, and higher scores indicated higher levels of depressive symptoms (Cronbach's α = .86).

    Month 3, Month 9

  • Caregiving Competency at Month 3 and Month 9

    Caregiving competency was measured by the Caregiving Competence Scale. It is a 4-point Likert (not at all, just a little, somewhat, very much) scale including four questions: How do you believe that you've learned to deal with very difficult situations? How much do you feel that all in all, you're a good caregiver? How competent do you feel? How self-confident do you feel? We summed the scores of four items with higher scores indicating larger competence (Cronbach's alpha=0.62). The range of the score is 0-16.

    Month 3, Month 9

  • Loneliness at Month 3 and Month 9

    Loneliness was assessed by the Revised-University of California at Los Angeles Loneliness Scale. Caregivers rated their feelings of lacking companionship, left out of life, and isolation from others respectively on a 3-point scale (hardly ever, sometimes, often). We added up scores for the three questions to produce a continuous variable ranging from 0 to 6, with higher scores indicating higher levels of loneliness (Cronbach's alpha = 0.80).

    Month 3, Month 9

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.

Behavioral: Peer Mentoring Program

Control group

NO INTERVENTION

The control group received a package of educational materials on knowledge of dementia, caregiving skills.

Interventions

The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.

Treatment group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The caregivers will be recruited if they:
  • self-identify as Chinese
  • are 21 years old or older
  • speak Mandarin or Cantonese Chinese
  • provide care to a family member with dementia or cognitive impairment related to dementia for 10 hours or more a week
  • are interested in receiving peer mentoring
  • report moderate to severe caregiver burden
  • can access a telephone and communicate via phone call.
  • The volunteer mentors will be recruited if they:
  • are 50 years old or older
  • self-identify as Chinese
  • speak Mandarin or Cantonese Chinese
  • have experience providing care to a family member with dementia or cognitive impairment related to dementia
  • can access a telephone and communicate via phone call
  • can attend volunteering training in person
  • +2 more criteria

You may not qualify if:

  • do not self-identify as Chinese
  • do not speak Mandarin or Cantonese Chinese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

Related Publications (1)

  • Liu J, Cheung ESL, Lou Y, Wu B. A peer mentoring program for Chinese American dementia caregivers: a pilot randomized controlled trial. Aging Ment Health. 2024 Nov;28(11):1479-1488. doi: 10.1080/13607863.2024.2346599. Epub 2024 May 2.

MeSH Terms

Conditions

Caregiver BurdenPsychological Well-Being

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Results Point of Contact

Title
Associate Professor
Organization
Columbia University

Study Officials

  • Jinyu Liu, PhD

    Baylor University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 15, 2020

Study Start

July 1, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations