NCT05390333

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 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

April 11, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

May 20, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

Family CaregiverCaregiver Stress

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Self-Care Sampler for Family Care Partners

OTHER

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.

Behavioral: Self-Care Sampler for Family Carer Partners

Interventions

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.

Self-Care Sampler for Family Care Partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center, Dartmouth Centers for Health and Aging

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (8)

  • Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. doi: 10.1177/01939450222045716.

    PMID: 11829276BACKGROUND
  • 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: 24618967BACKGROUND
  • 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: 27265709BACKGROUND
  • 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: 25114532BACKGROUND
  • 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.

    PMID: 29542299BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 12646602BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Ellen Flaherty, Ph. D

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President Geriatric Center of Excellence, Principal Investigator

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

April 11, 2022

Primary Completion

October 27, 2022

Study Completion

November 2, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations