Alzheimer's DiseaseNCT02347202
Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention
A study testing Online counseling via Zoom teleconferencing and Telephone support as needed in people with Alzheimer's Disease and Dementia, run by NYU Langone Health at 1 site in United States.
Trial summary
A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). Read more about this study
- Who is it for?
- Ages 21 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Online counseling via Zoom teleconferencing and Telephone support as needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 4 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 to 125 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for caregivers to become research participants include:
- access to an Internet-connected computer with a camera, microphone, and speakers either at home, or at another location that affords privacy;
- fluent in spoken and written English; and
- caregivers who participate must be spouses or partners of people with dementia living with them at home when they enter the study. In addition, all caregivers must have at least one family member (or close friend) with whom they are in communication about the person with dementia, and/or their issues related to being a caregiver, who can participate in family counseling sessions; if not, they are excluded from the study.
- Inclusion criteria for counselors to be research participants in both the pilot study and the RCT:
- Certified or Master's level social worker, a nurse with an RN and at least two years' experience working with older adults and their family members evaluated on an individual basis by the PIs);
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- counselors who have received training online or in person in conducting the NYUCI and provided the intervention to at least one caregiver in person;
- counselors who have completed the online training to conduct the NYUCI via videoconferencing;
- counselors who have demonstrated the ability to contact caregivers and families via videoconferencing by interacting with HealthCare Interactive (HCI) staff in mock sessions (HCI is the technology developer for this Phase II effort); and
- counselors who have confirmed they have personal liability and malpractice insurance.
Who cannot join
- no access or severely limited access to an Internet-connected computer with a camera;
- not fluent in spoken and written English;
- not having a family member with whom they are in communication about the person with dementia; and
- apparent severe mental or physical illness (e.g., self report of clinical depression).
- not a certified or Master's level social worker or nurse with an RN and at least two years' experience working with older adults and their family members, or other professional with at last two years' experience working with older adults and their family members (to be decided by the PIs);
- counselors who have not received training online or in person in conducting the NYUCI;
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- counselors who have not completed the online training to conduct the NYUCI via videoconferencing;
- counselors who cannot demonstrate ability to contact caregivers and families via videoconferencing by interacting with HCI; and
- counselors who do not have personal liability and malpractice insurance.
Trial locations and contacts
1 site in 1 country.
About this study
A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling and support for families involved in the care of a relative or friend with Alzheimer's Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced caregiver's depressive symptoms, improved their physical health, and extended the time persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634, formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889).
The intervention is now being widely implemented in-person, but there are barriers that prevent many caregivers from receiving its benefits, including geographic distance; impediments to older adults leaving their homes; and travel considerations for counselors which make it impossible to provide the NYUCI in person.
Read more
The goal of this study is to evaluate the efficacy of an online videoconferencing version of the NYUCI. This innovative application has massive implications for social service delivery to older adults, because it will make it possible to deliver an in-person intervention, via the internet, which is already evidenced based to older adult caregivers who cannot currently be served. It will create the online reservation and management technology linking counselors with families as well as the evidence of effectiveness of providing such services via secure video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling (TTDC) and related online educational training modules will connect skilled providers to the families of persons with dementia without regard to geographic location. Implications for rural healthcare delivery are particularly persuasive. To the investigators knowledge, this will be the first large-scale TTDC to be developed and rigorously tested with a randomized controlled trial. The investigators hypothesize that such a system, coupled with online training for providers and families on tele- counseling and distance caregiving, will have similar benefits to those achieved with in-person counseling during the original NYUCI RCT.
This project includes an online reservation and management technology linking counselors with families via secure videoconferencing vehicles. The Telehealth Technology for Distance Counseling (TTDC), and online technology developed as part of this overall effort, will connect skilled providers to the families of persons with dementia without regard to geographic location. The related online clinical modules (i.e., interactive, computer-based educational materials) developed as a part of this grant effort will prepare counselors to provide the intervention, and caregivers to utilize the internet software, to be able to participate in counseling.
The TTDC will include a scheduling system to link counselors to families at their mutual convenience and assure delivery in a cost-effective manner. The TTDC has the additional potential to transform ADRD care in ethnic and culturally diverse communities by connecting highly trained NYUCI counselors with specialized language and cultural skills to families who would not have access to these resources locally.
In this study investigators will have 240 caregivers navigate the online educational module and the online reservation system for connecting caregivers with social workers. Half of the caregivers will then be paired with social service providers to receive counseling over the telephone, and the other half with be paired with social service providers to receive counseling via Zoom, a video conferencing program. Recruiting across the United States and Toronto, Canada.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Online counseling via Zoom teleconferencing, Telephone support as needed
- Keywords
- Counseling
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online counseling via Zoom teleconferencingOther
Telephone support as neededOther
| Study group | Role | What they receive |
|---|---|---|
| Online counseling via Zoom teleconferencing | Experimental | Each participant will be assigned a random number which is linked to group assignment. The numbers will be assigned consecutively to participants as they enroll. All caregivers in the treatment group will receive 6 counseling sessions in 4 months, using teleconferencing. The first session will be an individual session. The caregiver will be asked to select family members to participate in the next 4 sessions. The 4 family sessions will be followed by another individual session with the spouse/partner caregiver. The counselor will send the primary caregiver an email to be forwarded to family members with instructions on how to access the TTDC training on using the teleconferencing technology. All caregivers in the control group will be able to call the counselor for resource information and support. Receives: Other: Online counseling via Zoom teleconferencing |
| Telephone support as needed | Other | All caregivers in the control group will be able to call the counselor for resource information and support as needed. Receives: Other: Telephone support as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in depressive symptoms between groups (One-way analysis of variance, questionnaire)
One-way analysis of variance to evaluate differences in depressive symptoms between groups. This data will be collected via a questionnaire.
Measured: Four, eight, and twelve months after intervention
Differences in reactions to problem behaviors between groups (questionnaire)
This information will be collected via a questionnaire.
Measured: Four, eight, and twelve months after intervention
Differences in satisfaction with social support between groups (questionnaire)
This information will be collected via a questionnaire.
Measured: Four, eight, and twelve months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startOct 2015
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary S Mittelman, DrPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347202
- Sponsor's protocol ID
- 14-01185
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2015
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention
- ClinicalTrials.gov ID
- NCT02347202
- Acronym / sponsor ID
- 14-01185
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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.
A 20+ year randomized controlled trial (RCT) demonstrated the many benefits of a counseling and support intervention for spouse caregivers, the NYU Caregiver Intervention (NYUCI). The NYU Caregiver Intervention (NYUCI) is an evidence-based intervention that provides counseling and support for families involved in the care of a relative or friend with Alzheimer's Disease and Related Dementias (ADRD). Most notably, the NYUCI substantially reduced caregiver's depressive symptoms, improved their physical health, and extended the time persons with ADRD remained at home by an average of 1.5 years (Mittelman et al., AG14634, formerly MH42216; See http://www.ncbi.nlm.nih.gov/pubmed/17101889).
The intervention is now being widely implemented in-person, but there are barriers that prevent many caregivers from receiving its benefits, including geographic distance; impediments to older adults leaving their homes; and travel considerations for counselors which make it impossible to provide the NYUCI in person.
The goal of this study is to evaluate the efficacy of an online videoconferencing version of the NYUCI. This innovative application has massive implications for social service delivery to older adults, because it will make it possible to deliver an in-person intervention, via the internet, which is already evidenced based to older adult caregivers who cannot currently be served. It will create the online reservation and management technology linking counselors with families as well as the evidence of effectiveness of providing such services via secure video teleconferencing vehicles. The proposed Telehealth Technology for Distance Counseling (TTDC) and related online educational training modules will connect skilled providers to the families of persons with dementia without regard to geographic location. Implications for rural healthcare delivery are particularly persuasive. To the investigators knowledge, this will be the first large-scale TTDC to be developed and rigorously tested with a randomized controlled trial. The investigators hypothesize that such a system, coupled with online training for providers and families on tele- counseling and distance caregiving, will have similar benefits to those achieved with in-person counseling during the original NYUCI RCT.
This project includes an online reservation and management technology linking counselors with families via secure videoconferencing vehicles. The Telehealth Technology for Distance Counseling (TTDC), and online technology developed as part of this overall effort, will connect skilled providers to the families of persons with dementia without regard to geographic location. The related online clinical modules (i.e., interactive, computer-based educational materials) developed as a part of this grant effort will prepare counselors to provide the intervention, and caregivers to utilize the internet software, to be able to participate in counseling.
The TTDC will include a scheduling system to link counselors to families at their mutual convenience and assure delivery in a cost-effective manner. The TTDC has the additional potential to transform ADRD care in ethnic and culturally diverse communities by connecting highly trained NYUCI counselors with specialized language and cultural skills to families who would not have access to these resources locally.
In this study investigators will have 240 caregivers navigate the online educational module and the online reservation system for connecting caregivers with social workers. Half of the caregivers will then be paired with social service providers to receive counseling over the telephone, and the other half with be paired with social service providers to receive counseling via Zoom, a video conferencing program. Recruiting across the United States and Toronto, Canada.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online counseling via Zoom teleconferencing | Experimental | Other: Online counseling via Zoom teleconferencingEach participant will be assigned a random number which is linked to group assignment. The numbers will be assigned consecutively to participants as they enroll. All caregivers in the treatment group will receive 6 counseling sessions in 4 months, using teleconferencing. The first session will be an individual session. The caregiver will be asked to select family members to participate in the next 4 sessions. The 4 family sessions will be followed by another individual session with the spouse/partner caregiver. The counselor will send the primary caregiver an email to be forwarded to family members with instructions on how to access the TTDC training on using the teleconferencing technology. All caregivers in the control group will be able to call the counselor for resource information and support. |
| Telephone support as needed | Other | Other: Telephone support as neededAll caregivers in the control group will be able to call the counselor for resource information and support as needed. |
Who may qualify
- Ages
- 21 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- access to an Internet-connected computer with a camera, microphone, and speakers either at home, or at another location that affords privacy;
- fluent in spoken and written English; and
- caregivers who participate must be spouses or partners of people with dementia living with them at home when they enter the study. In addition, all caregivers must have at least one family member (or close friend) with whom they are in communication about the person with dementia, and/or their issues related to being a caregiver, who can participate in family counseling sessions; if not, they are excluded from the study.
- Inclusion criteria for counselors to be research participants in both the pilot study and the RCT:
- Certified or Master's level social worker, a nurse with an RN and at least two years' experience working with older adults and their family members evaluated on an individual basis by the PIs);
Key exclusion criteria (9 listed)
- no access or severely limited access to an Internet-connected computer with a camera;
- not fluent in spoken and written English;
- not having a family member with whom they are in communication about the person with dementia; and
- apparent severe mental or physical illness (e.g., self report of clinical depression).
- not a certified or Master's level social worker or nurse with an RN and at least two years' experience working with older adults and their family members, or other professional with at last two years' experience working with older adults and their family members (to be decided by the PIs);
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 |
|---|---|---|
| Online counseling via Zoom teleconferencing | Other | Online counseling via Zoom teleconferencing |
| Telephone support as needed | Other | Telephone support as needed |
Primary outcome
Differences in depressive symptoms between groups (One-way analysis of variance, questionnaire)
Time frame: Four, eight, and twelve months after intervention
One-way analysis of variance to evaluate differences in depressive symptoms between groups. This data will be collected via a questionnaire.
Differences in reactions to problem behaviors between groups (questionnaire)
Time frame: Four, eight, and twelve months after intervention
This information will be collected via a questionnaire.
Differences in satisfaction with social support between groups (questionnaire)
Time frame: Four, eight, and twelve months after intervention
This information will be collected via a questionnaire.
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 11 Jan 2022.
- Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease.Link 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.
Mary S Mittelman, DrPH principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online counseling via Zoom teleconferencing and Telephone support as needed in people with Alzheimer's Disease and Dementia, run by NYU Langone Health 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 10 inclusion and 9 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in depressive symptoms between groups (One-way analysis of variance, questionnaire) (time frame: Four, eight, and twelve months after intervention). 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?
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 11 Jan 2022.