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Video-Enhanced Care Management for Medically Complex Veterans

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962687
Recruitment Status : Completed
First Posted : November 11, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Multimorbidity Cognitive Impairments Behavioral: Care management via videoconference Behavioral: Care management via telephone calls Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Video-Enhanced Care Management for Medically Complex Veterans
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : February 28, 2018

Arm Intervention/treatment
Experimental: Videoconference care management
12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing
Behavioral: Care management via videoconference
12-week nurse care management for medically complex Veterans with CI delivered via videoconference

Active Comparator: Telephone care management
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Behavioral: Care management via telephone calls
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls




Primary Outcome Measures :
  1. Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat [ Time Frame: 14 weeks ]
    Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.

  2. Number of Scheduled Intervention Phone or Video Calls Completed by Participants [ Time Frame: 14 weeks ]
    Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.

  3. Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI [ Time Frame: 14 weeks ]
    Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).


Other Outcome Measures:
  1. Number of Participants With Hospitalizations or Emergency Department Visits [ Time Frame: 14 weeks ]
    Descriptive analysis of emergency department visits and hospitalizations in the two study arms

  2. Physical Activity [ Time Frame: 14 weeks ]
    Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)

  3. Quality of Life Outcome [ Time Frame: 14 weeks ]
    Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)

  4. Depression [ Time Frame: 14 weeks ]
    Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)

  5. Social Support [ Time Frame: 14 weeks ]
    Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)

  6. Anxiety [ Time Frame: 14 weeks ]
    Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Unable to communicate on the telephone, or no telephone access for duration of study
  • Currently hospitalized or incapacitated
  • Enrolled in a study that prohibits participation in another study

Information from the National Library of Medicine

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): NCT02962687


Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Susan N. Hastings, MD Durham VA Medical Center, Durham, NC
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02962687     History of Changes
Other Study ID Numbers: PPO 15-425
First Posted: November 11, 2016    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Veterans
Cognitive impairments
Nursing care management
Videoconferencing
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders