- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05390333
Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress
November 21, 2022 updated by: Ellen Flaherty, Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03766
- Dartmouth Hitchcock Medical Center, Dartmouth Centers for Health and Aging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Self-Care Sampler for Family Care 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress, as measured by Modified Caregiver Strain Index change
Time Frame: Baseline, week 1 change Post-Intervention, week 6
|
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:
|
Baseline, week 1 change Post-Intervention, week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ellen Flaherty, Ph. D, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. doi: 10.1177/01939450222045716.
- 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.
- Biddle S. Physical activity and mental health: evidence is growing. World Psychiatry. 2016 Jun;15(2):176-7. doi: 10.1002/wps.20331. No abstract available.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2022
Primary Completion (Actual)
October 27, 2022
Study Completion (Actual)
November 2, 2022
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
November 22, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY02001401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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