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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05390333
Other study ID # STUDY02001401
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2022
Est. completion date November 2, 2022

Study information

Verified date November 2022
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effectiveness of the Self-care Sampler for Family Care Partners program in reducing caregiver stress over the 6-week program period. Hypothesis: Participants who attend the 6 class sessions over 6 weeks of the program will have a lower score on the Modified Caregiver Strain Index (MCSI) when compared to baseline. This will indicate a decrease in overall stress.


Description:

The 6-week Self-Care Sampler for Family Caregivers program was created to provide a variety of evidence-based self-care practices that improve the mental and physical health of caregivers by relieving stress and encouraging preventive health behaviors (Acton, 2002). To determine the effectiveness of the Self-care Sampler for Family Care Partners program in reducing caregiver stress over the 6-week program period. Hypothesis: Participants who attend the 6 class sessions over 6 weeks of the program will have a lower score on the Modified Caregiver Strain Index (MCSI) when compared to baseline. This will indicate a decrease in overall stress. For each 6-week program, sessions will take place once a week for 90 minutes, each starting with a centering exercise and focusing on a new form of self-care. The program gives caregivers a space to connect with others and form social bonds that could extend outside of our sessions. We will run the 6-week Self-Care Sampler for Family Caregivers program three times (three intervention periods) in 2022.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date November 2, 2022
Est. primary completion date October 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any relative, partner, friend or neighbor who has a significant personal relationship with, and provides a broad range of assistance for, an older person or an adult with a chronic or disabling condition. Exclusion Criteria: - Those who cannot speak English which would prevent full participation - Those with hearing, vision, or cognitive impairment that prevents participation over video - Individuals who are not adults - Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-Care Sampler for Family Carer Partners
The 6-week Self-Care Sampler for Family Caregivers program was created to provide a variety of evidence-based self-care practices that improve the mental and physical health of caregivers by relieving stress. Sessions will take place once a week for 90 minutes, each starting with a centering exercise and focusing on a new form of self-care. The first 30 minutes will be used for a support group and the last 60 minutes will be for a self-care practice. Self-care practices that will be offered throughout the 6 weeks include mindfulness, mindful drawing, exercise, and health prevention and promotion.

Locations

Country Name City State
United States Dartmouth Hitchcock Medical Center, Dartmouth Centers for Health and Aging Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Cigna

Country where clinical trial is conducted

United States, 

References & Publications (8)

Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. — View Citation

Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304. Review. — View Citation

Biddle S. Physical activity and mental health: evidence is growing. World Psychiatry. 2016 Jun;15(2):176-7. doi: 10.1002/wps.20331. — View Citation

Iavarone A, Ziello AR, Pastore F, Fasanaro AM, Poderico C. Caregiver burden and coping strategies in caregivers of patients with Alzheimer's disease. Neuropsychiatr Dis Treat. 2014 Jul 29;10:1407-13. doi: 10.2147/NDT.S58063. eCollection 2014. — View Citation

Jang SH, Lee JH, Lee HJ, Lee SY. Effects of Mindfulness-Based Art Therapy on Psychological Symptoms in Patients with Coronary Artery Disease. J Korean Med Sci. 2018 Mar 19;33(12):e88. doi: 10.3346/jkms.2018.33.e88. — View Citation

Kabat-Zinn J. Indra's net at work: The mainstreaming of Dharma practice in society. The psychology of awakening: Buddhism, science, and our day-to-day lives. York Beach, ME, US: Samuel Weiser; 2000. p. 225-49.

Lykins ELB, Baer RA. Psychological functioning in a sample of long-term practitioners of mindfulness meditation. Journal of Cognitive Psychotherapy. 2009;23(3):226-41. doi: 10.1891/0889-8391.23.3.226.

Thornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32. doi: 10.1093/geronb/58.2.s127. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stress, as measured by Modified Caregiver Strain Index change This index includes questions that measure the perception of persistent problems and feelings of decreased well-being that results from providing prolonged care. Respondents will provide one of the following responses to each of 13 questions:
Yes, on a regular basis (2 points)
Yes, sometimes (1 point)
No (0 points) These questions will be presented to the participants in a survey prior to the program and after the program. Scoring ranges from 26 to 0 with a higher score indicates a higher level of caregiver strain.
Baseline, week 1 change Post-Intervention, week 6
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