NCT02962687

Brief Summary

The purpose of this study is to examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with cognitive impairment, delivered via telephone or videoconferencing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

October 25, 2016

Results QC Date

February 15, 2019

Last Update Submit

September 12, 2019

Conditions

Keywords

VeteransCognitive impairmentsNursing care managementVideoconferencing

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat

    Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.

    14 weeks

  • Number of Scheduled Intervention Phone or Video Calls Completed by Participants

    Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.

    14 weeks

  • Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI

    Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).

    14 weeks

Other Outcomes (6)

  • Number of Participants With Hospitalizations or Emergency Department Visits

    14 weeks

  • Physical Activity

    14 weeks

  • Quality of Life Outcome

    14 weeks

  • +3 more other outcomes

Study Arms (2)

Videoconference care management

EXPERIMENTAL

12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing

Behavioral: Care management via videoconference

Telephone care management

ACTIVE COMPARATOR

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Behavioral: Care management via telephone calls

Interventions

12-week nurse care management for medically complex Veterans with CI delivered via videoconference

Videoconference care management

12-week nurse care management for medically complex Veterans with CI delivered via telephone calls

Telephone care management

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Receive primary care from a Durham Veterans Affairs Medical Center (VAMC) affiliated primary care clinic (1 visit within the previous 12 months)
  • Age \> or = 65
  • CAN score \> or = 90
  • Valid telephone number in the medical record
  • Identifies a friend or family member that we may contact for study participation as the Care Partner
  • Telephone Instrument for Cognitive Status - modified (TICS-m) score 20-31

You may not qualify if:

  • Cognitive impairment or dementia (identified via ICD diagnosis codes or Primary Care Provider note in previous 2 years)
  • Enrolled in or have an active consult for a special population Patient Aligned Care Teams (PACT), e.g.:
  • GeriPACT
  • Home Based Primary Care
  • Mental Health
  • Post-Deployment, etc.
  • Serious mental illness defined as diagnosis of psychosis of any type:
  • schizophrenia
  • bipolar disorder
  • psychiatric hospitalization in the previous year
  • or current high-risk suicide flag in their Computerized Patient Record System (CPRS) medical record
  • Active substance abuse, documented in the medical record within the previous year
  • Eligible for hospice, palliative care, or prognosis of less than 6 months to live
  • Lacks decision-making capacity, documented in the medical record
  • Referred to institutional care or residing in nursing home
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Limitations and Caveats

Perceived value associated with each delivery method was removed as an outcome on 2/13/19 because data are being analyzed as qualitative data; there are no quant data to report.

Results Point of Contact

Title
Susan N Hastings
Organization
Durham VA HSR&D

Study Officials

  • Susan N. Hastings, MD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 11, 2016

Study Start

May 31, 2017

Primary Completion

February 12, 2018

Study Completion

February 28, 2018

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.

Locations