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Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms (VIP-HANA)

Primary Purpose

HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIP app without HIV-related symptom strategies.
VIP app that delivers HIV-related symptom strategies.
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV (Human Immunodeficiency Virus) focused on measuring HIV/AIDS Health Management App, HIV/AIDS symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. HIV+
  2. Age 18 or over
  3. Able to read and respond in English
  4. Reside within the US
  5. Willing to participate in an online survey.

Exclusion Criteria:

  1. HIV-negative
  2. under age 18
  3. Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.

Sites / Locations

  • Columbia University School for Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

VIP app that delivers HIV-related symptom strategies

VIP app without HIV-related symptom strategies

Outcomes

Primary Outcome Measures

Symptom Burden Score
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).

Secondary Outcome Measures

Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms.

Full Information

First Posted
May 11, 2017
Last Updated
November 21, 2019
Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03182738
Brief Title
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Acronym
VIP-HANA
Official Title
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. The investigators hypothesize that VIP-HANA will improve symptom frequency and intensity.
Detailed Description
As PLWHA age, they are developing chronic illnesses and co-morbid conditions that are often seen in older HIV negative patients. HANA conditions (e.g., cardiovascular disease, liver disease, diabetes, and asthma) are becoming more common as PLWHA age. An individual's ability to identify and self-manage symptoms of HIV illness has been shown to improve patient outcomes and quality of life. The investigators will develop and pilot test the Video Information Provider (VIP), a web application (app) that delivered HIV-related symptom self-care strategies for PLWHA for 13 common (non-HANA) HIV/AIDS symptoms. There is a need to identify the symptom experience of PLWHA with HANA conditions. The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
Keywords
HIV/AIDS Health Management App, HIV/AIDS symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
VIP app that delivers HIV-related symptom strategies
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
VIP app without HIV-related symptom strategies
Intervention Type
Behavioral
Intervention Name(s)
VIP app without HIV-related symptom strategies.
Intervention Description
The control group will receive the VIP app without HIV-related symptom strategies
Intervention Type
Behavioral
Intervention Name(s)
VIP app that delivers HIV-related symptom strategies.
Intervention Description
The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
Primary Outcome Measure Information:
Title
Symptom Burden Score
Description
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).
Time Frame
Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)
Secondary Outcome Measure Information:
Title
Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Description
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms.
Time Frame
Baseline, 3 months, and 6 months
Other Pre-specified Outcome Measures:
Title
Change in Score on SF-12
Description
12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.
Time Frame
3 months and 6 months
Title
Score on Engagement With Health Care Provider Scale
Description
Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider.
Time Frame
Baseline, 3 months, and 6 months
Title
Score of the VAS
Description
The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose.
Time Frame
Baseline, 3 months, and 6 months
Title
Score on Fried's Frailty Phenotype
Description
Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores.
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV+ Age 18 or over Able to read and respond in English Reside within the US Willing to participate in an online survey. Exclusion Criteria: HIV-negative under age 18 Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Schnall, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School for Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32538796
Citation
Cho H, Porras T, Flynn G, Schnall R. Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study. J Med Internet Res. 2020 Jun 15;22(6):e17708. doi: 10.2196/17708.
Results Reference
derived

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Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms

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