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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03593564
Other study ID # KINDER 18-01-06
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date November 8, 2023

Study information

Verified date November 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot study will test the effect of an online asynchronous psychoeducational intervention to improve relationship quality and prevent verbal-type elder mistreatment in caregiving dyads. The investigators will use a pre-post test design to test the feasibility and acceptability of this video-based intervention, and to determine the likelihood that participation in this program may improve caregiver relationship quality.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date November 8, 2023
Est. primary completion date November 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Provides assistance to someone over the age of 60 with an illness or a disability ("care recipient") who requires personal assistance from another person (e.g., bathing, preparing meals). (Assistance provided with at least 1 activity of daily living and/or at least 2 instrumental activities of daily living.) - Person receiving care from the study participant has a cognitive impairment. This does not have to be diagnosed. - Participant provides at least 8 hours of assistance to the care recipient per week - Participant does not intend to place the care recipient in a skilled nursing facility or assisted living facility within 3 months of consenting into the study Exclusion Criteria: - Does not read and speak English - Cannot access a computer and internet (needed to complete lessons)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
KINDER
KINDER is an online course for people assisting an older adult with dementia. It is intended to improve the quality of caregiver's relationship with the care recipient and reduce the chance of risky relationship behavior (e.g., yelling). Courses will cover topics including understanding cognitive impairments, navigating evolving roles, and dealing with frustration. During this course, participants will learn skills to deal with difficult situations caregivers frequently encounter in ways that support a healthy caregiving relationship. Videos will be story-based and represent different types of caregiving relationships and challenges encountered.

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California Archstone Foundation

Country where clinical trial is conducted

United States, 

References & Publications (11)

Acierno R, Hernandez MA, Amstadter AB, Resnick HS, Steve K, Muzzy W, Kilpatrick DG. Prevalence and correlates of emotional, physical, sexual, and financial abuse and potential neglect in the United States: the National Elder Mistreatment Study. Am J Public Health. 2010 Feb;100(2):292-7. doi: 10.2105/AJPH.2009.163089. Epub 2009 Dec 17. — View Citation

Beach SR, Schulz R, Williamson GM, Miller LS, Weiner MF, Lance CE. Risk factors for potentially harmful informal caregiver behavior. J Am Geriatr Soc. 2005 Feb;53(2):255-61. doi: 10.1111/j.1532-5415.2005.53111.x. — View Citation

Cohen, S, Williamson, G. Perceived stress in a probability sample of the United States. In S. Spacapan & S. Oskamp (Eds.), The social psychology of health: Claremont Symposium on applied social psychology. Newbury Park, CA: Sage, 1988

Conrad KJ, Iris M, Ridings JW, Langley K, Anetzberger GJ. Self-report measure of psychological abuse of older adults. Gerontologist. 2011 Jun;51(3):354-66. doi: 10.1093/geront/gnq103. Epub 2010 Dec 20. — View Citation

DeLiema M, Gassoumis ZD, Homeier DC, Wilber KH. Determining prevalence and correlates of elder abuse using promotores: low-income immigrant Latinos report high rates of abuse and neglect. J Am Geriatr Soc. 2012 Jul;60(7):1333-9. doi: 10.1111/j.1532-5415.2012.04025.x. Epub 2012 Jun 14. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583. — View Citation

Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available. — View Citation

Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741. — View Citation

Straus, M. A., Hamby, S. L., Boney-McCoy, S., Sugarman, D. B. The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of Family Issues 17(3): 283-316, 1996.

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in frequency of verbal mistreatment This scale will measure frequency of verbal mistreatment using a measure based on the Conflict Tactics Scale (Straus et al., 1996), with additional questions from other items (Acierno et al., 2010; Beach et al., 2005; Conrad et al., 2011; Deliema et al., 2012) This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
Primary Change in the number of positive aspects of the relationship with the care recipient (Dyadic Relationship Scale) Participants are asked how much they agree with positive statements about their relationship with the care receiver on a 0 to 3 scale. This item comes from Sebern & Whitlatch (2007) This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
Secondary Change in caregiver competence (Caregiving Competence Scale) We will use the Caregiving Competence Scale developed by Pearlin and colleagues (1990) This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Secondary Change in perceived stress (Perceived Stress Scale) We will use the Perceived Stress Scale developed by Cohen & Williamson (1988) This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Secondary Change in caregiver burden (Zarit Burden Index) We will use the Zarit Burden Index developed by Zarit and colleagues (1980) This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Secondary Change in depression (Patient Health Questionnaire-9) We will use the Patient Health Questionnaire-9 (Kroenke et al., 2001) This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Secondary Change in caregiver mastery (Caregiver Mastery Scale) We will use the Caregiver Mastery Scale developed by Pearlin & Schooler (1978) This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
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