Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT05390333
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress, as measured by Modified Caregiver Strain Index change', 'timeFrame': 'Baseline, week 1 change Post-Intervention, week 6', 'description': '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:\n\n* Yes, on a regular basis (2 points)\n* Yes, sometimes (1 point)\n* 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Family Caregiver', 'Caregiver Stress'], 'conditions': ['Caregiver Stress']}, 'referencesModule': {'references': [{'pmid': '11829276', 'type': 'BACKGROUND', 'citation': 'Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. doi: 10.1177/01939450222045716.'}, {'pmid': '24618967', 'type': 'BACKGROUND', '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.'}, {'pmid': '27265709', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25114532', 'type': 'BACKGROUND', '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."}, {'pmid': '29542299', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12646602', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Those who cannot speak English which would prevent full participation\n* Those with hearing, vision, or cognitive impairment that prevents participation over video\n* Individuals who are not adults\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT05390333', 'briefTitle': 'Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress', 'orgStudyIdInfo': {'id': 'STUDY02001401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Self-Care Sampler for Family Care Partners', '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. 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.', 'interventionNames': ['Behavioral: Self-Care Sampler for Family Carer Partners']}], 'interventions': [{'name': 'Self-Care Sampler for Family Carer Partners', 'type': 'BEHAVIORAL', '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. 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.', 'armGroupLabels': ['Self-Care Sampler for Family Care Partners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center, Dartmouth Centers for Health and Aging', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Ellen Flaherty, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cigna', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President Geriatric Center of Excellence, Principal Investigator', 'investigatorFullName': 'Ellen Flaherty', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}