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Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02347202
First received: January 9, 2015
Last updated: March 3, 2017
Last verified: March 2017
  Purpose

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 Intervention
Alzheimer's Disease
Dementia
Other: Online counseling via Zoom teleconferencing
Other: Telephone support as needed

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Tools for Distance Delivery of an Evidence-based AD Family Caregiver Intervention

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: October 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 125 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for caregivers to become research participants include:

  1. access to an Internet-connected computer with a camera, microphone, and speakers either at home, or at another location that affords privacy;
  2. fluent in spoken and written English; and
  3. 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:

  1. 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);
  2. counselors who have received training online or in person in conducting the NYUCI and provided the intervention to at least one caregiver in person;
  3. counselors who have completed the online training to conduct the NYUCI via videoconferencing;
  4. 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
  5. counselors who have confirmed they have personal liability and malpractice insurance.

Exclusion Criteria:

Exclusion criteria for caregivers to be participants are:

  1. no access or severely limited access to an Internet-connected computer with a camera;
  2. not fluent in spoken and written English;
  3. not having a family member with whom they are in communication about the person with dementia; and
  4. apparent severe mental or physical illness (e.g., self report of clinical depression).

Exclusion criteria for counselors include:

  1. 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);
  2. counselors who have not received training online or in person in conducting the NYUCI;
  3. counselors who have not completed the online training to conduct the NYUCI via videoconferencing;
  4. counselors who cannot demonstrate ability to contact caregivers and families via videoconferencing by interacting with HCI; and
  5. counselors who do not have personal liability and malpractice insurance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02347202

Contacts
Contact: Tadessech Hailu, MS 646-754-2291 tadessech.hailu@nyumc.org

Locations
United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Tadessech Hailu    646-754-2291    tadessech.hailu@nyumc.org   
Principal Investigator: Mary S Mittelman, DrPH         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Mary S Mittelman, DrPH NYU School of Medicine
  More Information

Additional Information:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02347202     History of Changes
Other Study ID Numbers: 14-01185
Study First Received: January 9, 2015
Last Updated: March 3, 2017

Keywords provided by New York University School of Medicine:
Counseling

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on March 29, 2017