mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV)

NCT02897141 | Completed Results

• 2 other identifiers: AAAP1258R21HS023963
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to facilitate the dissemination and implementation of patient centered outcomes research using mHealth technology to improve self-management of adverse symptoms in persons living with HIV/AIDS (PLWH). Symptom management in PLWH is especially important because the US HIV epidemic continues to exact a huge toll, especially among Agency for Healthcare Research and Quality (AHRQ) priority populations including racial, ethnic, and sexual minorities and low-income persons. The incorporation of HIV symptom management strategies into patients' lives through the use of mHealth technologies has the potential to advance the effective dissemination and implementation of patient centered outcomes research findings.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIV; Health Management App; HIV symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Status From Baseline to Week 12

  Change in Symptom Status calculates the difference in symptom scores between the intervention and control groups at baseline versus follow-up after 12 weeks. Symptom scores were determined using the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev), where participants who reported experiencing any one of the 13 symptoms in the past 7 days were asked how much it bothered them (a little bit, somewhat, quite a bit, or very much). Instances where the symptom did not bother the individual were coded as "0" whereas instances where the symptom bothered the individual any amount were recoded as "1". The overall difference between groups at baseline and after 12 weeks ("difference of differences") falls within a range of -1 to 1, where lower numbers indicate the symptom bothered the person less, while higher numbers indicate it bothered them more. With the Difference Between Groups, a more negative score (closer to -1) represents a better outcome.

  Baseline and 12 weeks

Secondary Outcomes (5)

• Change in Quality of Life -- RAND-36

  Baseline and 12 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS)-29

  12 weeks

• Engagement With Healthcare Provider

  Baseline and 12 weeks

• Medication Adherence

  12 weeks

• Health-IT Usability Evaluation Scale (Health-ITUES)

  12 weeks

Study Arms (2)

mVIP group

EXPERIMENTAL

This group will receive targeted symptom strategies via a Health Management App developed from the UCSF symptom management manual based on the symptoms that they report. This is the intervention app group.

Device: Health Management App with symptom strategies

Attention Control Group

PLACEBO COMPARATOR

This group will received an app without symptom strategies, pre-loaded on their smartphones. This is the control app group.

Device: Control App

Interventions

Health Management App with symptom strategies DEVICE

The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.

mVIP group

Control App DEVICE

The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies

Attention Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HIV/AIDS
• Over the age of 18 years
• Able to provide written informed consent
• Able to communicate in English
• Health literacy level of marginal or inadequate (as measured by the Newest Vital Sign (NVS): total score of 3 or lower)
• Report at least 2 HIV related adverse symptoms in the past week
• Owner of a smart phone/tablet.

You may not qualify if:

• Inability to communicate in English
• Documented diagnosis of dementia
• Pregnancy
• Unable to understand consent procedure
• Self-reporting no adverse symptoms within the past week. (HIV-related symptoms include: anxiety, constipation, cough, depression, diarrhea, dizziness, fever, forgetfulness, fatigue, nausea, night sweats, neuropathy, shortness of breath, dermatitis, swelling of arms, hand, legs, feet, insomnia, weight loss, oral thrush, and vaginal itching, burning and discharge)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University School for Nursing

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Participants wanted reminders and login information sent via text instead of email. Both groups wanted summary reports of symptoms. Self-care strategy videos did not have sound. Generalizability is limited due to smartphone/tablet requirement.

Results Point of Contact

• Title: Dr. Rebecca Schnall
• Organization: Columbia University

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, MPH, RN-BC, FAAN

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: December 12, 2016
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: March 26, 2019
• Results First Posted: October 10, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)