Caregiver StressNCT05390333
Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress
A study testing Self-Care Sampler for Family Carer Partners in people with Caregiver Stress, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress
- What is being tested?
- Self-Care Sampler for Family Carer Partners
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center, Dartmouth Centers for Health and Aging
Lebanon, New Hampshire, 03766
About this study
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.
Read the 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.
- Conditions
- Caregiver Stress
- Being tested
- Self-Care Sampler for Family Carer Partners
- Keywords
- Family Caregiver, Caregiver Stress
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care Sampler for Family Carer PartnersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Care Sampler for Family Carer Partners |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 1 change Post-Intervention, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start11 Apr 2022
- Primary completion27 Oct 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cigna
- Responsible party
- Principal investigator, Ellen Flaherty, Dartmouth-Hitchcock Medical Center
- Investigators
- Ellen Flaherty, Ph. D, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390333
- Sponsor's protocol ID
- STUDY02001401
- Status last verified
- Nov 2022
- First submitted
- 20 May 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. doi: 10.1177/01939450222045716.
PubMed 11829276Adelman 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.
PubMed 24618967Biddle 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.
PubMed 27265709Iavarone 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.
PubMed 25114532Jang 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.
PubMed 29542299Kabat-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.
PubMed 12646602
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effectiveness of Self-Care Sampler for Family Care Partners in Reducing Caregiver Stress
- ClinicalTrials.gov ID
- NCT05390333
- Acronym / sponsor ID
- STUDY02001401
- Conditions
- Caregiver Stress
- Keywords
- Family Caregiver, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Cigna
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Care Sampler for Family Care Partners | Other | Behavioral: Self-Care Sampler for Family Carer PartnersThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Care Sampler for Family Carer PartnersThe 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. | Behavioural | Self-Care Sampler for Family Care Partners |
Primary outcome
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: * 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 11829276Acton GJ. Health-promoting self-care in family caregivers. West J Nurs Res. 2002 Feb;24(1):73-86. doi: 10.1177/01939450222045716.
- Background: PubMed 24618967Adelman 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.
- Background: PubMed 27265709Biddle 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.
- Background: PubMed 25114532Iavarone 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.
- Background: PubMed 29542299Jang 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.
- BackgroundKabat-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.
- BackgroundLykins 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: PubMed 12646602Thornton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Flaherty, Ph. D principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Sampler for Family Carer Partners in people with Caregiver Stress, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress, as measured by Modified Caregiver Strain Index change (time frame: Baseline, week 1 change Post-Intervention, week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390333, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.