Alzheimer's Disease (Incl Subtypes)NCT03218982
Vietnamese Caregiver Intervention Study
A study testing Enhanced psycho-education about dementia and caregiving in people with Alzheimer's Disease (Incl Subtypes) and Cognitive Impairment, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer's Disease (Incl Subtypes), Cognitive Impairment
- What is being tested?
- Enhanced psycho-education about dementia and caregiving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 31 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregivers will be included if they (a) are Vietnamese; (b) are age 21+; (c) speak Vietnamese and/or English (d) provide day-to-day, hands on care to a family member with Alzheimer's disease (AD) or cognitive impairment related to AD (e) have at least one family member who will also participate in the intervention; (f) volunteer informed consent; (g) are physically able to participate; and (g) expect to stay in the Sacramento area for the duration of the study
- Care recipients will be included if they are (a) Vietnamese; (b) are age 21+; (c) have reported Alzheimer's disease (AD) or cognitive impairment related to AD; (d) have at least one caregiver who is participating in the intervention (e) volunteer informed consent or surrogate consent, and (f) expect to stay in the Sacramento area for the duration of the study
Who cannot join
- If the care recipient expresses dissent to participation or to the use of surrogate consent, then he/she will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population
The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. This will be done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their care recipient) into an active intervention or a control condition and monitoring findings at baseline, post-intervention, and at three months.The intervention will consist of multiple components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD) and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who the primary caregiver identifies as providing him/her with the most support will be invited to join all components, but the intervention will be flexible depending on caregivers' needs/preferences. The care recipient is not required to join the sessions but will be able to if he/she or the family wishes. During the intervention, community partners will provide respite care for the care recipient.
Read the detailed description
Twenty-four (24) caregivers, the identified secondary caregiver, and a care recipient will be randomly assigned into the active intervention or a control condition: 16 triads in the intervention condition, 8 in the control.
For the primary caregivers: Primary caregivers will attend six weekly intervention sessions lasting 2 hours each. Based on previous Randomized Controlled Trials (RCTs) of a successful behavior change (i.e., smoking cessation) intervention in Vietnamese using only 2-3 sessions, six sessions were chosen as a middle ground. In the first 45 minutes, primary caregivers and a secondary caregiver (who the primary caregiver identifies) will participate in family psycho-education delivered by a Master's level trained, bilingual facilitator. Each group will consist of no more than four dyads (4 different groups totaling 16 dyads). The curriculum will be adapted based on what the Alzheimer's Association and REACH II have successfully used as well as what the University of California (UC) Davis Alzheimer's Disease Center (ADC) has implemented. The sessions will cover the following: a clinical model of dementia and helping family members come to a shared understanding of the nature and cause of dementia. The innovative component is a discussion of cultural values typical of individuals in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies. This is important because it will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Subsequent sessions will help caregivers learn skills and develop self-efficacy in dealing with patient symptoms, accessing resources (e.g., in-home support), and gaining family support in culturally-congruent ways. Facilitating the use of formal and informal support is a critical piece as Vietnamese caregivers may be looking for basic and concrete assistance rather than help in coping with caregiving.
The last part of the intervention is mindful Tai Chi that was chosen for several reasons. In a recent review and meta-analysis, Tai Chi showed beneficial effects on depression, anxiety, stress management, and self-efficacy. Second, Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness. An RCT of Tai Chi recently was successfully completed in Vietnam, demonstrating its growing acceptance in the Vietnamese population. The protocol will be adapted to meet caregivers' needs and highlight meditation that involves accepting stressful circumstances, thus capitalizing on emotion regulation strategies.
For the care recipients: Care recipients will receive the Montreal Cognitive Assessment (MoCA) measure to assess their mental status at baseline. The purpose of the Quality of Life - Alzheimer's Disease (QoL-AD) measure is to assess the caregiver intervention affects the care recipient's quality of life. The total time to complete these questionnaires is about 30 minutes per session.
Participants not randomized to the active intervention will receive educational materials/pamphlets on dementia and occasional phone-calls by research assistants to maintain contact, as is the standard of care in most caregiver intervention studies. Including a control condition will allow for mirroring of the actual larger trial as closely as possible, and also ascertain the feasibility of randomization.
- Being tested
- Enhanced psycho-education about dementia and caregiving
- Keywords
- Caregiver, Vietnamese, Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced psycho-education about dementia and caregivingBehavioural
Also called management of problem behaviors, facilitation of support-seeking, mindful Tai Chi
Enhanced psycho-education re dementia and caregiving helping family members come to shared understanding of the nature and cause of dementia. Discussion of cultural values in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Other sessions will teach skills to develop self-efficacy in dealing with patient symptoms, to access resources (e.g., in-home support), and to gain family support in culturally-congruent ways. Mindful Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Six weekly intervention sessions (2 hours, each) that include enhanced psycho-education and discussion of AD and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. Receives: Behavioral: Enhanced psycho-education about dementia and caregiving |
| Control | No intervention | Participants will receive educational materials/pamphlets on dementia and occasional phone-calls by research assistants to maintain contact, as is the standard of care in most caregiver intervention studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomization
% of eligible dyads who agree to randomization
Measured: assessed once all 3-month follow-ups are complete
Retention
Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained
Measured: assessed once all 3-month follow-ups are complete
Caregiver Intervention Adherence
% of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions
Measured: assessed at end of study, once all 3-month follow-ups are complete
Treatment Fidelity
Extent to which the facilitator adheres to the intervention protocol, as measured by a self-report checklist, with a goal of 85% adherence to key elements
Measured: assessed once all 3-month follow-ups are complete
Administration of Study Measures
% of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data
Measured: assessed at end of study, once all 3-month follow-ups are complete
Acceptability
Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.
Measured: 2 years
Secondary outcomes (6)
Alzheimer's Disease Knowledge Scale (ADKS)
This scale assesses knowledge about AD. The scale has 30 statements. Subjects are asked to rate each statement as True or False.
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Caregiver Self-Efficacy
Asks the caregiver about how confident in their ability to keep up their own activities and also respond to caregiving situations. The Scale includes 10 items, and asks caregivers to rate their confidence in handling situations on a scale from 1 to 10.
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Center for Epidemiological Studies Depression (CES-D) scale
This is a self-report depression scale that asks how many times during the past week a person has felt symptoms of depression. There are 20 items.
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Zarit Burden Inventory (ZBI)
This is a caregiver self-report measure that contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Quality of Life - Alzheimer's Disease (QoL-AD)
The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. It was developed for individuals with dementia, based on patient, caregiver, and expert input, to maximize construct validity, and to ensure that the measure focuses on quality of life domains thought to be important in cognitively impaired older adults. It uses simple and straightforward language and responses \& includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality.
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Perceived Stress Scale
This scale asks subjects about how often they have felt or thought about 10 items during the past month.
Measured: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start22 May 2017
- Primary completion1 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (Incl Subtypes)Studies of the same condition, open and under way.
- 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
- Families will then be randomized (as a team) to either the active intervention or the control condition. Caregivers in the active intervention will then be scheduled for six weekly intervention sessions, lasting about 2 hours each. Following the completion of the sessions, primary caregivers will complete assessment measures (that they completed at baseline) immediately after the intervention (post) and at three months. This is expected to take one hour for each assessment. Primary caregivers assigned to the control condition will also complete these assessment measures around the same those in the active intervention complete them. These caregivers will also have the option of participating in the active intervention after the three-month follow up.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Oanh Meyer, PhD, MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218982
- Sponsor's protocol ID
- 823071
- Other IDs
- K01AG052646
- Status last verified
- Oct 2021
- First submitted
- 12 Jun 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Meyer OL, Nguyen KH, Dao TN, Vu P, Arean P, Hinton L. The Sociocultural Context of Caregiving Experiences for Vietnamese Dementia Family Caregivers. Asian Am J Psychol. 2015 Sep;6(3):263-272. doi: 10.1037/aap0000024. Epub 2015 Jun 15.
PubMed 26617956Resnick B, Ory MG, Hora K, Rogers ME, Page P, Bolin JN, Lyle RM, Sipe C, Chodzko-Zajko W, Bazzarre TL. A proposal for a new screening paradigm and tool called Exercise Assessment and Screening for You (EASY). J Aging Phys Act. 2008 Apr;16(2):215-33. doi: 10.1123/japa.16.2.215.
PubMed 18483443Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.
PubMed 12218768Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
PubMed 2594878Carpenter BD, Balsis S, Otilingam PG, Hanson PK, Gatz M. The Alzheimer's Disease Knowledge Scale: development and psychometric properties. Gerontologist. 2009 Apr;49(2):236-47. doi: 10.1093/geront/gnp023. Epub 2009 Mar 25.
PubMed 19363018Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.
PubMed 12028884Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
PubMed 16250744Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
PubMed 11574710Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003 Aug;43(4):514-20. doi: 10.1093/geront/43.4.514. No abstract available.
PubMed 12937330Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PubMed 12021425Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Phan T, Steel Z, Silove D. An ethnographically derived measure of anxiety, depression and somatization: the Phan Vietnamese Psychiatric Scale. Transcult Psychiatry. 2004 Jun;41(2):200-32. doi: 10.1177/1363461504043565.
PubMed 15446721
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population
- ClinicalTrials.gov ID
- NCT03218982
- Acronym / sponsor ID
- 823071
- Keywords
- Caregiver, Vietnamese, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Alzheimer's Association
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 17 Jul 2017 (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.
The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. This will be done by randomly assigning a family triad (primary caregiver, secondary caregiver, and their care recipient) into an active intervention or a control condition and monitoring findings at baseline, post-intervention, and at three months.The intervention will consist of multiple components -enhanced psycho-education that includes discussion of Alzheimer's Disease (AD) and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. A secondary caregiver who the primary caregiver identifies as providing him/her with the most support will be invited to join all components, but the intervention will be flexible depending on caregivers' needs/preferences. The care recipient is not required to join the sessions but will be able to if he/she or the family wishes. During the intervention, community partners will provide respite care for the care recipient.
Detailed description
Twenty-four (24) caregivers, the identified secondary caregiver, and a care recipient will be randomly assigned into the active intervention or a control condition: 16 triads in the intervention condition, 8 in the control.
For the primary caregivers: Primary caregivers will attend six weekly intervention sessions lasting 2 hours each. Based on previous Randomized Controlled Trials (RCTs) of a successful behavior change (i.e., smoking cessation) intervention in Vietnamese using only 2-3 sessions, six sessions were chosen as a middle ground. In the first 45 minutes, primary caregivers and a secondary caregiver (who the primary caregiver identifies) will participate in family psycho-education delivered by a Master's level trained, bilingual facilitator. Each group will consist of no more than four dyads (4 different groups totaling 16 dyads). The curriculum will be adapted based on what the Alzheimer's Association and REACH II have successfully used as well as what the University of California (UC) Davis Alzheimer's Disease Center (ADC) has implemented. The sessions will cover the following: a clinical model of dementia and helping family members come to a shared understanding of the nature and cause of dementia. The innovative component is a discussion of cultural values typical of individuals in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies. This is important because it will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Subsequent sessions will help caregivers learn skills and develop self-efficacy in dealing with patient symptoms, accessing resources (e.g., in-home support), and gaining family support in culturally-congruent ways. Facilitating the use of formal and informal support is a critical piece as Vietnamese caregivers may be looking for basic and concrete assistance rather than help in coping with caregiving.
The last part of the intervention is mindful Tai Chi that was chosen for several reasons. In a recent review and meta-analysis, Tai Chi showed beneficial effects on depression, anxiety, stress management, and self-efficacy. Second, Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness. An RCT of Tai Chi recently was successfully completed in Vietnam, demonstrating its growing acceptance in the Vietnamese population. The protocol will be adapted to meet caregivers' needs and highlight meditation that involves accepting stressful circumstances, thus capitalizing on emotion regulation strategies.
For the care recipients: Care recipients will receive the Montreal Cognitive Assessment (MoCA) measure to assess their mental status at baseline. The purpose of the Quality of Life - Alzheimer's Disease (QoL-AD) measure is to assess the caregiver intervention affects the care recipient's quality of life. The total time to complete these questionnaires is about 30 minutes per session.
Participants not randomized to the active intervention will receive educational materials/pamphlets on dementia and occasional phone-calls by research assistants to maintain contact, as is the standard of care in most caregiver intervention studies. Including a control condition will allow for mirroring of the actual larger trial as closely as possible, and also ascertain the feasibility of randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Families will then be randomized (as a team) to either the active intervention or the control condition. Caregivers in the active intervention will then be scheduled for six weekly intervention sessions, lasting about 2 hours each. Following the completion of the sessions, primary caregivers will complete assessment measures (that they completed at baseline) immediately after the intervention (post) and at three months. This is expected to take one hour for each assessment. Primary caregivers assigned to the control condition will also complete these assessment measures around the same those in the active intervention complete them. These caregivers will also have the option of participating in the active intervention after the three-month follow up.
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Behavioral: Enhanced psycho-education about dementia and caregivingSix weekly intervention sessions (2 hours, each) that include enhanced psycho-education and discussion of AD and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitation of support seeking, and mindful Tai Chi. |
| Control | No intervention | –Participants will receive educational materials/pamphlets on dementia and occasional phone-calls by research assistants to maintain contact, as is the standard of care in most caregiver intervention studies. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers will be included if they (a) are Vietnamese; (b) are age 21+; (c) speak Vietnamese and/or English (d) provide day-to-day, hands on care to a family member with Alzheimer's disease (AD) or cognitive impairment related to AD (e) have at least one family member who will also participate in the intervention; (f) volunteer informed consent; (g) are physically able to participate; and (g) expect to stay in the Sacramento area for the duration of the study
- Care recipients will be included if they are (a) Vietnamese; (b) are age 21+; (c) have reported Alzheimer's disease (AD) or cognitive impairment related to AD; (d) have at least one caregiver who is participating in the intervention (e) volunteer informed consent or surrogate consent, and (f) expect to stay in the Sacramento area for the duration of the study
Key exclusion criteria (1 listed)
- If the care recipient expresses dissent to participation or to the use of surrogate consent, then he/she will be excluded from the study.
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 |
|---|---|---|
| Enhanced psycho-education about dementia and caregivingAlso: management of problem behaviors, facilitation of support-seeking, mindful Tai ChiEnhanced psycho-education re dementia and caregiving helping family members come to shared understanding of the nature and cause of dementia. Discussion of cultural values in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Other sessions will teach skills to develop self-efficacy in dealing with patient symptoms, to access resources (e.g., in-home support), and to gain family support in culturally-congruent ways. Mindful Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness. | Behavioural | Active Intervention |
Primary outcome
Randomization
Time frame: assessed once all 3-month follow-ups are complete
% of eligible dyads who agree to randomization
Retention
Time frame: assessed once all 3-month follow-ups are complete
Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via number of participants retained
Caregiver Intervention Adherence
Time frame: assessed at end of study, once all 3-month follow-ups are complete
% of dyads engaging in the initial session, % completing at least 3 sessions, and % completing all sessions
Treatment Fidelity
Time frame: assessed once all 3-month follow-ups are complete
Extent to which the facilitator adheres to the intervention protocol, as measured by a self-report checklist, with a goal of 85% adherence to key elements
Administration of Study Measures
Time frame: assessed at end of study, once all 3-month follow-ups are complete
% of baseline, post-, and 3-month assessments completed (considering length of assessments and completeness of collected data
Acceptability
Time frame: 2 years
Assessed through a questionnaire and interview assessing the perceptions of the intervention by primary and secondary caregivers, CBO staff/administrators, and interventionists.
6 secondary outcomes
Alzheimer's Disease Knowledge Scale (ADKS)
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Caregiver Self-Efficacy
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Center for Epidemiological Studies Depression (CES-D) scale
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Zarit Burden Inventory (ZBI)
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
Perceived Stress Scale
Time frame: Baseline, 6-weeks (Post-intervention), 3 months post-intervention
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 Oct 2021.
- Background: PubMed 26617956Meyer OL, Nguyen KH, Dao TN, Vu P, Arean P, Hinton L. The Sociocultural Context of Caregiving Experiences for Vietnamese Dementia Family Caregivers. Asian Am J Psychol. 2015 Sep;6(3):263-272. doi: 10.1037/aap0000024. Epub 2015 Jun 15.
- Background: PubMed 18483443Resnick B, Ory MG, Hora K, Rogers ME, Page P, Bolin JN, Lyle RM, Sipe C, Chodzko-Zajko W, Bazzarre TL. A proposal for a new screening paradigm and tool called Exercise Assessment and Screening for You (EASY). J Aging Phys Act. 2008 Apr;16(2):215-33. doi: 10.1123/japa.16.2.215.
- Background: PubMed 12218768Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.
- Background: PubMed 2594878Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
- Background: PubMed 19363018Carpenter BD, Balsis S, Otilingam PG, Hanson PK, Gatz M. The Alzheimer's Disease Knowledge Scale: development and psychometric properties. Gerontologist. 2009 Apr;49(2):236-47. doi: 10.1093/geront/gnp023. Epub 2009 Mar 25.
- Background: PubMed 12028884Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.
- Background: PubMed 16250744Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 11574710Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
- Background: PubMed 12937330Schulz R, Burgio L, Burns R, Eisdorfer C, Gallagher-Thompson D, Gitlin LN, Mahoney DF. Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. Gerontologist. 2003 Aug;43(4):514-20. doi: 10.1093/geront/43.4.514. No abstract available.
- Background: PubMed 12021425Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Oanh Meyer, PhD, MAS principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced psycho-education about dementia and caregiving in people with Alzheimer's Disease (Incl Subtypes) and Cognitive Impairment, run by University of California, Davis 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 2 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 Oct 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?
Randomization (time frame: assessed once all 3-month follow-ups are complete). The study lists 6 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 NCT03218982, which also lists 13 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 Oct 2021.