Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Symptom Status From Baseline to Week 12
Study Overview
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.
Detailed Description
HIV has changed from an acute illness to a chronic disease. The success of HIV medications and treatments has significantly altered the course of the disease. While AIDS-related illnesses are no longer the primary threat, a new set of HIV-associated complications have emerged, resulting in a chronic disease that for many will span several decades of life. The ability to self-manage adverse symptoms of HIV illness has been shown to improve patient-centered outcomes. In response to this need, a team at University of California, San Francisco (UCSF) developed a paper-based symptom management manual with self-management strategies for 21 common HIV/AIDS adverse symptoms (PCOR evidence). The efficacy of the manual was demonstrated in a 775-person randomized controlled trial (RCT) over three months at 12 sites. However, subsequent use of these strategies has been very limited; mHealth offers an ideal platform for the implementation and dissemination of evidence-based strategies for HIV symptom management. Due to the high incidence of HIV among racial and ethnic minority populations, it is appropriate to develop mHealth tools tailored to the needs of these populations. mHealth technology has the potential to address many of the healthcare needs of persons living with HIV/AIDS (PLWH) including symptom management. In response to these current issues, this study seeks to inform the development and testing of a mHealth application that will incorporate findings from PCOR studies to improve the outcomes of PLWH. To improve outcomes for those most in need, study activities are focused on communities with the greatest burden of HIV in the US, including racial and ethnic minorities and those of low socioeconomic status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Inability to communicate in English
- •Documented diagnosis of dementia
- •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)
Arms & Interventions
mVIP group
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.
Intervention: Health Management App with symptom strategies (Device)
Attention Control Group
This group will received an app without symptom strategies, pre-loaded on their smartphones. This is the control app group.
Intervention: Control App (Device)
Outcomes
Primary Outcomes
Change in Symptom Status From Baseline to Week 12
Time Frame: Baseline and 12 weeks
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.
Secondary Outcomes
- Engagement With Healthcare Provider(Baseline and 12 weeks)
- Medication Adherence(12 weeks)
- Health-IT Usability Evaluation Scale (Health-ITUES)(12 weeks)
- Change in Quality of Life -- RAND-36(Baseline and 12 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29(12 weeks)
Investigators
Rebecca Schnall, RN, MPH, PhD
Assistant Professor of Nursing
Columbia University