Chronic GriefCGMI-VNCT03593070
Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention
A study testing Chronic Grief Management Intervention-Video in people with Chronic Grief and Dementia Family Caregivers, run by Rush University Medical Center at 1 site in United States.
Trial summary
The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Grief, Dementia Family Caregivers
- What is being tested?
- Chronic Grief Management Intervention-Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 21 years of age or older
- Identified as family member, fictive kin (self-identified family member), or partner of care recipient at any time post permanent placement of care in long-term care facility (LTCF)
- Care recipient has a documented ADRD diagnosis and resides in any type of unit in a LTCF
- Possessing self-reported basic computer literacy and in-home internet access
- Able to speak, read, and write English
- Not currently attending another ADRD caregiver grief management group
- Experiencing high to moderate levels of grief per screening with the Marwit-Meuser Caregiver Grief Inventory-Short Form (MMCGI-SF) (70 and above); and/or
- Experiencing high levels of depressive symptoms per screening with Patient Health Questionnaire-9 (PHQ-9) (scores 10 and above)
Who cannot join
- Non English speaker, reader, writer
- Scoring under the cut off points on the MM-CGI-SF and the PHQ-9
- Reporting no basic computer literacy; no internet access
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612-3806
About this study
The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms, dissatisfaction with care, and conflict with long-term care facility staff. This study will test the effects of a cost effective chronic grief management intervention to be delivered using an online platform (Adobe Connect) and iPads. The study aims to decrease dementia caregivers' chronic grief, depressive and anxiety symptoms, and to improve their positive states of mind; to improve satisfaction with care post-placement and to attenuate caregivers' conflict with facility staff.
Read the detailed description
Evidence indicates that Alzheimer's disease or a related dementia (ADRD) family caregivers suffer long-term mental and physical health effects that place them at risk for premature death. They do not relinquish their role after placing a family member with Alzheimer's disease or a related dementia (ADRD) in long-term care. In fact, these caregivers experience increased symptoms of depression, symptoms of anxiety, and chronic grief post-placement. In the long-term care (LTC) environment, caregivers' chronic grief is exacerbated by their lack of knowledge about late-stage Alzheimer's disease or a related dementia (ADRD) and their sense of loss, guilt, and role captivity. Interventions targeting improvement of ADRD caregivers' mental health have focused overwhelmingly on in-home care. We tested a Chronic Grief Management Intervention (CGMI) with ADRD caregivers in in long-term care and found it feasible (recruitment, retention, and attendance). The Chronic Grief Management Intervention (CGMI) had significant effects on caregiver knowledge and mental health outcomes (heartfelt sadness/longing and guilt; aspects of chronic grief). Although caregivers reported high satisfaction with this intervention, many could not attend the 12 face-to-face group sessions due to the burden of time and competing responsibilities. Therefore, we reduced the number of sessions to 8 and adapted the Chronic Grief Management Intervention to be delivered as a live streaming video, online group intervention; Chronic Grief Management Intervention-Video (CGMI-V), using Adobe Connect (online platform) and iPads. We tested CGMI-V in a single group pilot study for feasibility (recruitment, retention, attendance and technology ease of use) with Alzheimer's disease or a related dementia (ADRD) caregivers post-placement. We obtained 100% retention with high caregiver satisfaction with the intervention and the online technology used to deliver it. Our proposed study, Chronic Grief Management: A Live Streaming Video, Online Intervention (CGMI-V) builds on these results and is guided by a Model of Dementia Caregiver Chronic Grief in the Long-Term Care Setting. The purpose of this study is to test the effects of the 8-week CGMI-V on a caregiver primary outcome (chronic grief); a secondary mental health outcome (symptoms of depression, symptoms of anxiety, and positive states of mind) and a secondary facility-related outcome (caregiver satisfaction with care and conflict with facility staff) related to a minimal treatment (MT) control group. We propose to test the group-based Chronic Grief Management Intervention-Video (CGMI-V) in a Stage I longitudinal, randomized clinical trial. 144 Alzheimer's disease or a related dementia (ADRD) caregivers whose family members reside in one of the participating long-term care facilities will be randomly assigned to either CGMI-V or MT condition. Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in 8 weekly live streaming video, online group sessions. Caregivers in the minimal treatment (MT) condition will receive written information about late-stage ADRD at baseline. For both conditions, data will be collected at baseline, 8 weeks (immediately post-intervention) and then at 24 weeks post-baseline, using measures of caregiver grief: Marwit-Meuser Caregiver Grief Inventory(MM-CGI); depressive symptoms: Center for Epidemiological Studies Depression Scale (CES-D); anxiety symptoms: Stait-Trait Anxiety Inventory (STAI); positive states of mind: Positive States of Mind Scale (POSMS); satisfaction with care: Family Perception of Care Tool (FPCT); conflict with facility staff: Family Perception of Caregiving Role (FPCR subscale), knowledge of Alzheimer's disease: Family Knowledge of Alzheimer's Test (FKAT), loss, guilt and role captivity (FPCR subscales). Specific aims are to: 1) Establish effect sizes of the Chronic Grief Management Intervention-Video (CGMI-V) condition and Minimal Treatment (MT) control condition on changes in caregiver chronic grief. 2) Establish effect sizes of the CGMI-V and Minimal Treatment (MT) control condition on changes in caregiver symptoms of depression and anxiety and on positive states of mind. 3) Establish effect sizes of the CGMI-V condition and the Minimal Treatment (MT) control condition on changes in caregiver satisfaction with care provided in the facility and conflict with staff, and 4) Explore mechanisms of intervention impact on all caregiver outcomes. Our long-term objective is to develop a chronic grief treatment modality that will be adopted in long-term care facilities as part of routine support for Alzheimer's disease or a related dementia caregivers post-placement. This in turn will impact public mental health for this growing segment of the population.
- Conditions
- Chronic Grief, Dementia Family Caregivers
- Being tested
- Chronic Grief Management Intervention-Video
- Keywords
- online group intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Grief Management Intervention-VideoBehavioural
Also called CGMI-V
The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
| Study group | Role | What they receive |
|---|---|---|
| CGMI-V | Experimental | Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. Receives: Behavioral: Chronic Grief Management Intervention-Video |
| Minimal Treatment (MT) | No intervention | Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marwit-Meuser Caregiver Grief Inventory (MM-CGI)
Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Secondary outcomes (5)
Change in Depressive Symptoms
Center for Epidemiological Studies Depression Scale (CES-D). The CES-D was assessed with 20-items, where responses are based on a four-point frequency rating (0 = rarely or none of the time to 3 = all of the time), with a possible range of 0 to 60. Larger scores represent more depressive symptoms, lower scores represent fewer symptoms.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Anxiety Symptoms
State-Trait Anxiety Inventory (STAI) was used to represent anxiety symptoms. The (STAI) includes 20 questions, with responses based on a scale of 1 to 4 (1 = almost never to 4 = almost always). Numeric responses to these questions are summed to produce an inventory score, with a possible range of 20-80, where higher scores indicate greater anxiety, and lower scores indicate less anxiety.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Positive States of Mind
Positive States of Mind Scale (PSOMS) was used to assess the extent to which caregivers were able to achieve six positive states of mind in the previous seven days. PSOM is based on 6 questions that are scored 0-4 and which are summed to produce scale scores that range from 0-24. Lower scores represent difficulty achieving positive states of mind in the past 7 days, higher scores indicate less difficulty achieving positive states of mind.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Conflict With Facility Staff
Conflict with facility staff was assessed with a subscale of 10 questions collected in the Family Perception of Caregiving Role (FPCR) tool. Scores on these 10 questions ranged from 1 (strongly disagree) to 7 (strongly agree). Response values associated with conflict subscale items were summed to produce total conflict scores ranging from 10-70. Lower scores indicate less conflict with facility staff, higher scores indicate more conflict with facility staff.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Satisfaction With Care
The Family Perception of Care Tool (FPCT) is comprised of 51 questions with 7-point likert-type responses where 1=strongly agree and 7=strongly disagree. When summed to create a total FPCT score, values ranged from 51-357. Higher scores in the FPCT represent more positive feelings towards staff whereas lower scores represent more negative feelings.
Measured: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Apr 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic GriefStudies of the same condition, open and under way.
- More trials run by Rush University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design The study is a Stage I longitudinal randomized clinical trial. Alzheimer's disease or a related dementia (ADRD) caregivers whose family members are in long-term care facilities will be recruited, screened for inclusion criteria, and will be randomly assigned to either Chronic Grief Management Intervention-Video (CGMI-V) or a Minimal Treatment (MT) condition. Caregivers in the CGMI-V condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. Those caregivers in the MT condition will receive written information materials about late-stage ADRD at baseline. For both conditions, data will be collected at baseline (pre-intervention), 8 weeks (immediately post-intervention) for intervention effects, and 24 week post baseline for maintenance effects. The design for this study was chosen to avoid the type of group clustering or contamination that would be engendered by the use of a randomized cluster design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olimpia Paun, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593070
- Sponsor's protocol ID
- 1R01AG056393-01A1
- Acronym
- CGMI-V
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paun O, Loukissa D, Chirica MG, Nowell HM 3rd. Loss and Grief in the Context of Dementia Caregiving. J Psychosoc Nurs Ment Health Serv. 2022 Oct;60(10):7-10. doi: 10.3928/02793695-20220909-01. Epub 2022 Oct 1.
PubMed 36179053
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention
- ClinicalTrials.gov ID
- NCT03593070
- Acronym / sponsor ID
- CGMI-V / 1R01AG056393-01A1
- Conditions
- Chronic Grief, Dementia Family Caregivers
- Keywords
- online group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms, dissatisfaction with care, and conflict with long-term care facility staff. This study will test the effects of a cost effective chronic grief management intervention to be delivered using an online platform (Adobe Connect) and iPads. The study aims to decrease dementia caregivers' chronic grief, depressive and anxiety symptoms, and to improve their positive states of mind; to improve satisfaction with care post-placement and to attenuate caregivers' conflict with facility staff.
Detailed description
Evidence indicates that Alzheimer's disease or a related dementia (ADRD) family caregivers suffer long-term mental and physical health effects that place them at risk for premature death. They do not relinquish their role after placing a family member with Alzheimer's disease or a related dementia (ADRD) in long-term care. In fact, these caregivers experience increased symptoms of depression, symptoms of anxiety, and chronic grief post-placement. In the long-term care (LTC) environment, caregivers' chronic grief is exacerbated by their lack of knowledge about late-stage Alzheimer's disease or a related dementia (ADRD) and their sense of loss, guilt, and role captivity. Interventions targeting improvement of ADRD caregivers' mental health have focused overwhelmingly on in-home care. We tested a Chronic Grief Management Intervention (CGMI) with ADRD caregivers in in long-term care and found it feasible (recruitment, retention, and attendance). The Chronic Grief Management Intervention (CGMI) had significant effects on caregiver knowledge and mental health outcomes (heartfelt sadness/longing and guilt; aspects of chronic grief). Although caregivers reported high satisfaction with this intervention, many could not attend the 12 face-to-face group sessions due to the burden of time and competing responsibilities. Therefore, we reduced the number of sessions to 8 and adapted the Chronic Grief Management Intervention to be delivered as a live streaming video, online group intervention; Chronic Grief Management Intervention-Video (CGMI-V), using Adobe Connect (online platform) and iPads. We tested CGMI-V in a single group pilot study for feasibility (recruitment, retention, attendance and technology ease of use) with Alzheimer's disease or a related dementia (ADRD) caregivers post-placement. We obtained 100% retention with high caregiver satisfaction with the intervention and the online technology used to deliver it. Our proposed study, Chronic Grief Management: A Live Streaming Video, Online Intervention (CGMI-V) builds on these results and is guided by a Model of Dementia Caregiver Chronic Grief in the Long-Term Care Setting. The purpose of this study is to test the effects of the 8-week CGMI-V on a caregiver primary outcome (chronic grief); a secondary mental health outcome (symptoms of depression, symptoms of anxiety, and positive states of mind) and a secondary facility-related outcome (caregiver satisfaction with care and conflict with facility staff) related to a minimal treatment (MT) control group. We propose to test the group-based Chronic Grief Management Intervention-Video (CGMI-V) in a Stage I longitudinal, randomized clinical trial. 144 Alzheimer's disease or a related dementia (ADRD) caregivers whose family members reside in one of the participating long-term care facilities will be randomly assigned to either CGMI-V or MT condition. Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in 8 weekly live streaming video, online group sessions. Caregivers in the minimal treatment (MT) condition will receive written information about late-stage ADRD at baseline. For both conditions, data will be collected at baseline, 8 weeks (immediately post-intervention) and then at 24 weeks post-baseline, using measures of caregiver grief: Marwit-Meuser Caregiver Grief Inventory(MM-CGI); depressive symptoms: Center for Epidemiological Studies Depression Scale (CES-D); anxiety symptoms: Stait-Trait Anxiety Inventory (STAI); positive states of mind: Positive States of Mind Scale (POSMS); satisfaction with care: Family Perception of Care Tool (FPCT); conflict with facility staff: Family Perception of Caregiving Role (FPCR subscale), knowledge of Alzheimer's disease: Family Knowledge of Alzheimer's Test (FKAT), loss, guilt and role captivity (FPCR subscales). Specific aims are to: 1) Establish effect sizes of the Chronic Grief Management Intervention-Video (CGMI-V) condition and Minimal Treatment (MT) control condition on changes in caregiver chronic grief. 2) Establish effect sizes of the CGMI-V and Minimal Treatment (MT) control condition on changes in caregiver symptoms of depression and anxiety and on positive states of mind. 3) Establish effect sizes of the CGMI-V condition and the Minimal Treatment (MT) control condition on changes in caregiver satisfaction with care provided in the facility and conflict with staff, and 4) Explore mechanisms of intervention impact on all caregiver outcomes. Our long-term objective is to develop a chronic grief treatment modality that will be adopted in long-term care facilities as part of routine support for Alzheimer's disease or a related dementia caregivers post-placement. This in turn will impact public mental health for this growing segment of the population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study Design The study is a Stage I longitudinal randomized clinical trial. Alzheimer's disease or a related dementia (ADRD) caregivers whose family members are in long-term care facilities will be recruited, screened for inclusion criteria, and will be randomly assigned to either Chronic Grief Management Intervention-Video (CGMI-V) or a Minimal Treatment (MT) condition. Caregivers in the CGMI-V condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. Those caregivers in the MT condition will receive written information materials about late-stage ADRD at baseline. For both conditions, data will be collected at baseline (pre-intervention), 8 weeks (immediately post-intervention) for intervention effects, and 24 week post baseline for maintenance effects. The design for this study was chosen to avoid the type of group clustering or contamination that would be engendered by the use of a randomized cluster design.
| Arm | Type | Receives |
|---|---|---|
| CGMI-V | Experimental | Behavioral: Chronic Grief Management Intervention-VideoCaregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. |
| Minimal Treatment (MT) | No intervention | –Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 21 years of age or older
- Identified as family member, fictive kin (self-identified family member), or partner of care recipient at any time post permanent placement of care in long-term care facility (LTCF)
- Care recipient has a documented ADRD diagnosis and resides in any type of unit in a LTCF
- Possessing self-reported basic computer literacy and in-home internet access
- Able to speak, read, and write English
Key exclusion criteria (3 listed)
- Non English speaker, reader, writer
- Scoring under the cut off points on the MM-CGI-SF and the PHQ-9
- Reporting no basic computer literacy; no internet access
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 |
|---|---|---|
| Chronic Grief Management Intervention-VideoAlso: CGMI-VThe CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date. | Behavioural | CGMI-V |
Primary outcome
Marwit-Meuser Caregiver Grief Inventory (MM-CGI)
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Marwit-Meuser Caregiver Grief Inventory (MM-CGI). Scores range from 50 to 250; higher scores represent higher levels of grief.
5 secondary outcomes
Change in Depressive Symptoms
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Anxiety Symptoms
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Positive States of Mind
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Conflict With Facility Staff
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Change in Satisfaction With Care
Time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36179053Paun O, Loukissa D, Chirica MG, Nowell HM 3rd. Loss and Grief in the Context of Dementia Caregiving. J Psychosoc Nurs Ment Health Serv. 2022 Oct;60(10):7-10. doi: 10.3928/02793695-20220909-01. Epub 2022 Oct 1.
- DOI: 10.3928/02793695-20220909-01Link provided by the sponsor.
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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.
Olimpia Paun, PhD principal investigator
Rush University 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 Chronic Grief Management Intervention-Video in people with Chronic Grief and Dementia Family Caregivers, run by Rush University 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 8 inclusion and 3 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 2024. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Marwit-Meuser Caregiver Grief Inventory (MM-CGI) (time frame: Measured at Baseline, 8 weeks, and 24 weeks, Baseline to 24 weeks reported.). 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 NCT03593070, which also lists 1 linked publication.
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 2024.