Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02347202|
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : January 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Dementia||Other: Online counseling via Zoom teleconferencing Other: Telephone support as needed||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Online counseling via Zoom teleconferencing
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.
Other: Online counseling via Zoom teleconferencing
Telephone support as needed
All caregivers in the control group will be able to call the counselor for resource information and support as needed.
Other: Telephone support as needed
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347202
|Contact: Tadessech Hailu, MSfirstname.lastname@example.org|
|United States, New York|
|NYU School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Tadessech Hailu 646-754-2291 email@example.com|
|Principal Investigator: Mary S Mittelman, DrPH|
|Principal Investigator:||Mary S Mittelman, DrPH||NYU School of Medicine|