Caregiver BurdenNCT04787068
Support for Caregivers of Older Adults With Cognitive Decline
A study testing Occupational Therapy support in people with Caregiver Burden and Depression, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Depression, Confidence, Self
- What is being tested?
- Occupational Therapy support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 31 May 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Caregivers of community-dwelling older adults (55 and over) who are member of the PACE
- Adult 21 years or older
- Living with the care recipient or within a distance so that they can visit him/her minimum once a week
- Cognitively intact (can recall three words immediately and 3 minutes later)
- Competent in English
Who cannot join
- One instrument (Positive aspect of caregiving) is only available in English. To fully understand caregivers' challenges and convey solutions, our current study OT graduate students are not competent enough in other languages to provide interventions. We do not have budget to hire interpreters.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York
Buffalo, New York, 14214
About this study
Official title: Providing Support to Caregivers of Frail Older Adults With Cognitive Impairments
This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. At baseline challenges that caregivers are facing will be expressed and individualized solutions will be identified and delivered for the treatment and educational material will be given to the control group. Two and four months later, follow up interview will be made to identify changes in burden, depression, fatigue, self-efficacy, and positive aspect of care giving. It is expected to show when the effectiveness becomes clear.
Read the detailed description
Family caregivers of frail older adults with cognitive impairments face special challenges in caring for their care recipients (CR) due to their fast declining health. Examples of difficulties include managing CR's behaviors and daily activities, as well as maintaining their own psychological and physical health, which result in high caregiver burden. The aim is to support these caregivers of older adults who are enrollees of the Program for All-inclusive Care for the Elderly (PACE) through occupational therapy (OT) interventions to reduce caregiver burden and depression, and increase positive aspects of caregiving and self-efficacy. Since PACE organizations offer limited support for caregivers due to understanding, supervised OT graduate students (OTGS) will provide caregivers with customized supports. By doing so, the students will gain precious experience before they enter the workforce. This proposal will develop and test the effectiveness of this collaborative model. This study will use a randomized controlled design with about a 4- month intervention period. The assessments will take place at baseline, 2 months and 4 months. The study period will be two years. Participants will be 60 convenience family caregivers of the PACE enrollees in Western New York; therefore, CRs are 55 years old or older, need a nursing home level of care, but remain living in the community. Caregivers are adults who visit the CR at least once a week. OTGS will contact the caregivers, using a phone, and conduct an in depth interview to understand their difficulties. Then solutions will be brainstormed amongst OTs and geriatric specialists, and interventions will be formed. At the first visit to the CRs' homes, interviews will be conducted using the Zarit Burden Interview, the Center for Epidemiology Study for Depression, the Buffalo Fatigue Scale, the Positive Aspect of Caregiving, and the Visual Analogue Scale for self-efficacy. The possible solutions will be discussed with caregivers and more detailed difficulties will be videotaped. The solutions that caregivers are comfortable with will be reviewed by the PACE Rehabilitation Department and need to be approved before their implementation. The solutions may include: education of disease process, training for caregivers in supporting CR's activities of daily living (ADL) and instrumental ADL, coordination of family caregivers, problematic behaviors, functional exercise, fall prevention, and increased number of CR's visits to a PACE daycare facility. Statistical analysis will use Generalized Estimating Equations to compare the two groups' linear trends. We expect CRs' condition will deteriorate but the treatment group will reduce caregiver burden and increase self-efficacy.
- Conditions
- Caregiver Burden, Depression, Confidence, Self, Cognition, Fatigue, Function
- Being tested
- Occupational Therapy support
- Keywords
- Informal caregivers, Intervention
- Medical subject headings
- Caregiver Burden, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy supportBehavioural
Intervention include (a) didactic education about diseases; (b) the use of errorless techniques to improve assistance for CR's Activities of Daily Living (ADL), Instrumental ADL, and communication tasks; (c) the use of incentives (e.g., providing a favorite scented shampoo); (e) use of a schedule/calendar on a computer, cell phone and/or blackboard in CR's home to coordinate caregiving tasks for family members; (f) suggesting more frequent PACE daycare visits or use of a nearby PACE, having a snack or short game to prevent going to bed right after dinner); (d) use of the Buffalo Functional Exercise for strengthening ( a home-based exercise developed for PACE by the PI and shown to be effective in preventing falls)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Intervention is occupational therapy support Receives: Behavioral: Occupational Therapy support |
| Control group | No intervention | No intervention was provided, only educational material was given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver burden measured by the Zarit Burden Interview
To measure changes in burden of care using the 22-item Zarit Burden Interview (ZBI). Each item is rated from Never (0), Rarely (1), Sometimes (2), Quite Frequently (3), to Nearly Always (4). Higher scores indicate higher burden. The ZBI is scored by adding up the responses of all items, ranging from 0 to 88. The interpretations of scores are: 0-20 (no burden), 21-40 (mild to moderate burden), 41-60 (moderate to severe burden), and 61-88 (severe burden). The ZBI has good internal consistency reliability and good validity, and scores were significantly positively correlated with behavior problems in the care recipients and depression scores of the caregivers, according to the study using caregivers (Herbert et al, 2000).
Measured: 4 months
Change in depression change measured by the Center for Epidemiology Studies-Depression
To measure changes in depression using the Center for Epidemiology Studies -Depression (CES-D). This scale asks how often a respondent experienced symptoms associated with depression within the past week. The scale is scored from 0 to 3, with 0 representing rarely or none of the time (less than one day), 1 representing some or a little of the time (1 to 2 days), 2 representing occasionally or a moderate amount of time (3 to 4 days), or 3 representing most or all of the time (5 to 7 days). Total scores could range from 0 (the lowest depression score) to 60 (the highest). A score of 16 or higher indicates a depressive symptom. The CES-D has high internal consistency (Cronbach's alpha =.90) (Cosco et al., 2017), and moderate test-retest reliability (the strongest occurring whiten one to three weeks of time), as well as good measurement validity (Gonzalez et al, 2016).
Measured: 4 months
Change in confidence to continue caring for the care recipient in the future (6 months)
To measure changes in confidence to confine caring for the care recipient using Visual Analogue Scale. It asks caregivers to rate their confidence on a scale of 1 to 10 on Visual Analogue Scale. This assessment asked the caregivers to rate themselves regarding their confidence in in caring for the care recipient in six months. A score of 1 represents no confidence, 5, mid-level confidence, and 10 represents completely confidence.
Measured: 4 months
Secondary outcomes (2)
Change in a cognitive level of care recipients measured by the Global Deterioration Scale
To measure changes in cognition using the Global Deterioration Scale (GDS). The GDS consists of levels 1 to 7. Level 1 indicates "no cognitive decline," Level 2, "very mild cognitive decline/ age associated memory impairment," Level 3, "mild cognitive decline," Level 4,"moderate cognitive decline," Level 5, "moderate dementia," Level 6, "moderately severe dementia," and Level 7, "severe dementia." Therefore, higher scores indicate lower cognition. The GDS has established concurrent validity when compared to the Mini-Mental State Exam with high correlation (Reisberg et al, 1994). It also demonstrated satisfactory clinical/biological validity, compared to CT scan measurements (r= 0.50 for sulcal enlargement scans and r= 0.60 for ventricular dilation scans) and cerebral blood flow (r= 0.70-0.80) (Herndon, 2006). The GDS also has high interrater reliability, ranging in various studies from 0.87 to 0.97 (Herndon, 2006).
Measured: 4 months
Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services
To measure changes in IADL using questionnaires in the Older Americans Resources and Services (OARS) Multidimensional Functional Assessment. The IADL has seven items: using a phone, getting to places out of walking distance, shopping for groceries or clothes, preparing own meals, doing housework, taking medication, and handling money. Each item is rated from 0 to 2: Score 0 indicates "completely unable to do the activity", 1," can do the activity with some help" and 2, "can do the activity without help". The total score ranges between 0 and 14 and higher scores indicate higher function. Intraclass Correlations (ICC) intrarater reliability for was .99 for a short interval (7-10 days) and a long interval (4-6 weeks), and the interrater reliability for a short interval was .98 and for a long interval, .91 (Ottenbacher et al., 1994).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start19 Jan 2018
- Primary completion2 Oct 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Ralph C. Wilson Jr. Foundation (Funding source)
- Responsible party
- Principal investigator, Machiko R Tomita, State University of New York at Buffalo
- Investigators
- Machiko R Tomita, Ph.D., Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787068
- Sponsor's protocol ID
- STUDY00001647
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Seeher K, Low LF, Reppermund S, Brodaty H. Predictors and outcomes for caregivers of people with mild cognitive impairment: a systematic literature review. Alzheimers Dement. 2013 May;9(3):346-55. doi: 10.1016/j.jalz.2012.01.012. Epub 2012 Nov 2.
PubMed 23123229Ottenbacher KJ, Mann WC, Granger CV, Tomita M, Hurren D, Charvat B. Inter-rater agreement and stability of functional assessment in the community-based elderly. Arch Phys Med Rehabil. 1994 Dec;75(12):1297-301.
PubMed 7993167Gonzalez P, Nunez A, Merz E, Brintz C, Weitzman O, Navas EL, Camacho A, Buelna C, Penedo FJ, Wassertheil-Smoller S, Perreira K, Isasi CR, Choca J, Talavera GA, Gallo LC. Measurement properties of the Center for Epidemiologic Studies Depression Scale (CES-D 10): Findings from HCHS/SOL. Psychol Assess. 2017 Apr;29(4):372-381. doi: 10.1037/pas0000330. Epub 2016 Jun 13.
PubMed 27295022Reisberg B, Sclan SG, Franssen E, Kluger A, Ferris S. Dementia staging in chronic care populations. Alzheimer Dis Assoc Disord. 1994;8 Suppl 1:S188-205. No abstract available.
PubMed 8068258Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x.
PubMed 18786017Dean K, Wilcock G. Living with mild cognitive impairment: the patient's and carer's experience. Int Psychogeriatr. 2012 Jun;24(6):871-81. doi: 10.1017/S104161021100264X. Epub 2012 Jan 17.
PubMed 22251799Austrom MG, Lu Y. Long term caregiving: helping families of persons with mild cognitive impairment cope. Curr Alzheimer Res. 2009 Aug;6(4):392-8. doi: 10.2174/156720509788929291.
PubMed 19689239Beinart N, Weinman J, Wade D, Brady R. Caregiver burden and psychoeducational interventions in Alzheimer's disease: a review. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):638-48. doi: 10.1159/000345777. Epub 2012 Dec 15.
PubMed 23341829Pinquart M, Sorensen S. Correlates of physical health of informal caregivers: a meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2007 Mar;62(2):P126-37. doi: 10.1093/geronb/62.2.p126.
PubMed 17379673
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Support to Caregivers of Frail Older Adults With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT04787068
- Acronym / sponsor ID
- STUDY00001647
- Conditions
- Caregiver Burden, Depression, Confidence, Self, Cognition, Fatigue, Function
- Keywords
- Informal caregivers, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Ralph C. Wilson Jr. Foundation (Funding source)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 8 Mar 2021 (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.
This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. At baseline challenges that caregivers are facing will be expressed and individualized solutions will be identified and delivered for the treatment and educational material will be given to the control group. Two and four months later, follow up interview will be made to identify changes in burden, depression, fatigue, self-efficacy, and positive aspect of care giving. It is expected to show when the effectiveness becomes clear.
Detailed description
Family caregivers of frail older adults with cognitive impairments face special challenges in caring for their care recipients (CR) due to their fast declining health. Examples of difficulties include managing CR's behaviors and daily activities, as well as maintaining their own psychological and physical health, which result in high caregiver burden. The aim is to support these caregivers of older adults who are enrollees of the Program for All-inclusive Care for the Elderly (PACE) through occupational therapy (OT) interventions to reduce caregiver burden and depression, and increase positive aspects of caregiving and self-efficacy. Since PACE organizations offer limited support for caregivers due to understanding, supervised OT graduate students (OTGS) will provide caregivers with customized supports. By doing so, the students will gain precious experience before they enter the workforce. This proposal will develop and test the effectiveness of this collaborative model. This study will use a randomized controlled design with about a 4- month intervention period. The assessments will take place at baseline, 2 months and 4 months. The study period will be two years. Participants will be 60 convenience family caregivers of the PACE enrollees in Western New York; therefore, CRs are 55 years old or older, need a nursing home level of care, but remain living in the community. Caregivers are adults who visit the CR at least once a week. OTGS will contact the caregivers, using a phone, and conduct an in depth interview to understand their difficulties. Then solutions will be brainstormed amongst OTs and geriatric specialists, and interventions will be formed. At the first visit to the CRs' homes, interviews will be conducted using the Zarit Burden Interview, the Center for Epidemiology Study for Depression, the Buffalo Fatigue Scale, the Positive Aspect of Caregiving, and the Visual Analogue Scale for self-efficacy. The possible solutions will be discussed with caregivers and more detailed difficulties will be videotaped. The solutions that caregivers are comfortable with will be reviewed by the PACE Rehabilitation Department and need to be approved before their implementation. The solutions may include: education of disease process, training for caregivers in supporting CR's activities of daily living (ADL) and instrumental ADL, coordination of family caregivers, problematic behaviors, functional exercise, fall prevention, and increased number of CR's visits to a PACE daycare facility. Statistical analysis will use Generalized Estimating Equations to compare the two groups' linear trends. We expect CRs' condition will deteriorate but the treatment group will reduce caregiver burden and increase self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Occupational Therapy supportIntervention is occupational therapy support |
| Control group | No intervention | –No intervention was provided, only educational material was given. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Caregivers of community-dwelling older adults (55 and over) who are member of the PACE
Key exclusion criteria (1 listed)
- One instrument (Positive aspect of caregiving) is only available in English. To fully understand caregivers' challenges and convey solutions, our current study OT graduate students are not competent enough in other languages to provide interventions. We do not have budget to hire interpreters.
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 |
|---|---|---|
| Occupational Therapy supportIntervention include (a) didactic education about diseases; (b) the use of errorless techniques to improve assistance for CR's Activities of Daily Living (ADL), Instrumental ADL, and communication tasks; (c) the use of incentives (e.g., providing a favorite scented shampoo); (e) use of a schedule/calendar on a computer, cell phone and/or blackboard in CR's home to coordinate caregiving tasks for family members; (f) suggesting more frequent PACE daycare visits or use of a nearby PACE, having a snack or short game to prevent going to bed right after dinner); (d) use of the Buffalo Functional Exercise for strengthening ( a home-based exercise developed for PACE by the PI and shown to be effective in preventing falls) | Behavioural | Treatment group |
Primary outcome
Change in caregiver burden measured by the Zarit Burden Interview
Time frame: 4 months
To measure changes in burden of care using the 22-item Zarit Burden Interview (ZBI). Each item is rated from Never (0), Rarely (1), Sometimes (2), Quite Frequently (3), to Nearly Always (4). Higher scores indicate higher burden. The ZBI is scored by adding up the responses of all items, ranging from 0 to 88. The interpretations of scores are: 0-20 (no burden), 21-40 (mild to moderate burden), 41-60 (moderate to severe burden), and 61-88 (severe burden). The ZBI has good internal consistency reliability and good validity, and scores were significantly positively correlated with behavior problems in the care recipients and depression scores of the caregivers, according to the study using caregivers (Herbert et al, 2000).
Change in depression change measured by the Center for Epidemiology Studies-Depression
Time frame: 4 months
To measure changes in depression using the Center for Epidemiology Studies -Depression (CES-D). This scale asks how often a respondent experienced symptoms associated with depression within the past week. The scale is scored from 0 to 3, with 0 representing rarely or none of the time (less than one day), 1 representing some or a little of the time (1 to 2 days), 2 representing occasionally or a moderate amount of time (3 to 4 days), or 3 representing most or all of the time (5 to 7 days). Total scores could range from 0 (the lowest depression score) to 60 (the highest). A score of 16 or higher indicates a depressive symptom. The CES-D has high internal consistency (Cronbach's alpha =.90) (Cosco et al., 2017), and moderate test-retest reliability (the strongest occurring whiten one to three weeks of time), as well as good measurement validity (Gonzalez et al, 2016).
Change in confidence to continue caring for the care recipient in the future (6 months)
Time frame: 4 months
To measure changes in confidence to confine caring for the care recipient using Visual Analogue Scale. It asks caregivers to rate their confidence on a scale of 1 to 10 on Visual Analogue Scale. This assessment asked the caregivers to rate themselves regarding their confidence in in caring for the care recipient in six months. A score of 1 represents no confidence, 5, mid-level confidence, and 10 represents completely confidence.
2 secondary outcomes
Change in a cognitive level of care recipients measured by the Global Deterioration Scale
Time frame: 4 months
Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services
Time frame: 4 months
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 8 Mar 2021.
- Background: PubMed 23123229Seeher K, Low LF, Reppermund S, Brodaty H. Predictors and outcomes for caregivers of people with mild cognitive impairment: a systematic literature review. Alzheimers Dement. 2013 May;9(3):346-55. doi: 10.1016/j.jalz.2012.01.012. Epub 2012 Nov 2.
- Background: PubMed 7993167Ottenbacher KJ, Mann WC, Granger CV, Tomita M, Hurren D, Charvat B. Inter-rater agreement and stability of functional assessment in the community-based elderly. Arch Phys Med Rehabil. 1994 Dec;75(12):1297-301.
- Background: PubMed 27295022Gonzalez P, Nunez A, Merz E, Brintz C, Weitzman O, Navas EL, Camacho A, Buelna C, Penedo FJ, Wassertheil-Smoller S, Perreira K, Isasi CR, Choca J, Talavera GA, Gallo LC. Measurement properties of the Center for Epidemiologic Studies Depression Scale (CES-D 10): Findings from HCHS/SOL. Psychol Assess. 2017 Apr;29(4):372-381. doi: 10.1037/pas0000330. Epub 2016 Jun 13.
- Background: PubMed 8068258Reisberg B, Sclan SG, Franssen E, Kluger A, Ferris S. Dementia staging in chronic care populations. Alzheimer Dis Assoc Disord. 1994;8 Suppl 1:S188-205. No abstract available.
- Results publication: PubMed 18786017Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x.
- Results publication: PubMed 22251799Dean K, Wilcock G. Living with mild cognitive impairment: the patient's and carer's experience. Int Psychogeriatr. 2012 Jun;24(6):871-81. doi: 10.1017/S104161021100264X. Epub 2012 Jan 17.
- Results publication: PubMed 19689239Austrom MG, Lu Y. Long term caregiving: helping families of persons with mild cognitive impairment cope. Curr Alzheimer Res. 2009 Aug;6(4):392-8. doi: 10.2174/156720509788929291.
- Results publication: PubMed 23341829Beinart N, Weinman J, Wade D, Brady R. Caregiver burden and psychoeducational interventions in Alzheimer's disease: a review. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):638-48. doi: 10.1159/000345777. Epub 2012 Dec 15.
- Results publication: PubMed 17379673Pinquart M, Sorensen S. Correlates of physical health of informal caregivers: a meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2007 Mar;62(2):P126-37. doi: 10.1093/geronb/62.2.p126.
- Identified current evidence of factors influencing dementia-related caregiver burdenLink provided by the sponsor.
- MCI results in significant challenges for both patients and their carers. Further work is required in order to establish the best way to help patients and carers meet these challengesLink provided by the sponsor.
- Describe common psychological and caregiving issues that can cause stress in family members of persons with mild cognitive impairment (PwMCI) in order to assist family members in providing care and support to the PwMCI while also caring for themselves ovLink provided by the sponsor.
- Interventions that are individually tailored to the caregiver are particularly effective at reducing caregiver burden and should be further investigatedLink provided by the sponsor.
- negative effects of caregiving on physical health are most likely to be found in psychologically distressed caregivers facing dementia-related stressors.Link provided by the sponsor.
- Depression and psychological comorbidity, although not as pronounced as in dementia caregivers, are common complications in MCI caregiversLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Machiko R Tomita, Ph.D. principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy support in people with Caregiver Burden and Depression, run by State University of New York at Buffalo 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 5 inclusion and 1 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 8 Mar 2021. 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?
Change in caregiver burden measured by the Zarit Burden Interview (time frame: 4 months). The study lists 3 primary outcomes in all. 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 NCT04787068, which also lists 9 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 8 Mar 2021.