- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02897141
mVIP (Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV) (mVIP)
Use of mHealth Technology for Supporting Symptom Management in Underserved Persons Living With HIV
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University School for Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Placebo Comparator: Attention Control Group
This group will received an app without symptom strategies, pre-loaded on their smartphones.
This is the control app group.
|
The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life -- RAND-36
Time Frame: Baseline and 12 weeks
|
36-Item Short Form Survey (RAND-36) is a widely-used 36-item tool to measure health-related quality of life, where each item in the scale is scored as 0, 25, 50, 75, or 100.
Scoring is a two-step process.
First, precoded numeric values are recoded per the scoring key so that all items are scored so that a high score defines a more favorable health state.
In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Scores represent the percentage of total possible score achieved.
In step 2, items in the same scale are averaged together to create the 8 scale scores, where a lower score may indicate a better outcome for some of the scales, while it may indicate a better outcome for others.
|
Baseline and 12 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time Frame: 12 weeks
|
The PROMIS-29 includes seven health related quality of life domains on a 5-point scale from a score of 1 to 5 and the pain domain has two subdomains (interference and intensity) where pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10).
Raw scores 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 the scoring tables listed in the PROMIS manuals.
A higher PROMIS T-score implies more of the concept being measured; for instance, a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates a greater severity of depression.
|
12 weeks
|
Engagement With Healthcare Provider
Time Frame: Baseline and 12 weeks
|
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 in which a lower score indicates a better outcome.
The scores are then collated to an aggregate score where the minimum value = 13 and the maximum value = 52.
A low score indicates greater provider engagement, where as higher scores indicate lower provider engagement (less favorable outcome).
The difference in scores at baseline and follow-up at three months was calculated within both the intervention and control groups, and the difference was then taken between the resulting means of those scores.
|
Baseline and 12 weeks
|
Medication Adherence
Time Frame: 12 weeks
|
Medication adherence was calculated by two scales: the Center for Adherence Support Evaluation (CASE) Adherence Index and the Visual Analogue Scale (VAS). The CASE Adherence Index consists of the composite scores of three questions evaluating self-reported measures of adherence. The minimum score on this scale is 3 while the maximum score on this scale is 16, with higher scores indicating better outcome. Scores greater than 10 indicate "good adherence," while scores less than or equal to 10 indicate poor adherence. The VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken from a scale of 0% to 100% in which 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. Consequently, a higher score (100%) indicates |
12 weeks
|
Health-IT Usability Evaluation Scale (Health-ITUES)
Time Frame: 12 weeks
|
Health Information Technology Usability Evaluation Scale (Health-ITUES) was used to measure usability.
Health-ITUES consists of 20 items rated on a 5-point Likert scale from strongly disagree (score of 1) to strongly agree (score of 5) measuring actual usage, intention to use, satisfaction, perceived usefulness, perceived ease of use, perceived performance speed, learnability, competency, flexibility/customizability, memorability, error prevention, information needs, and other outcomes.
A higher score (5) indicates higher usability.
Overall score was calculated as the mean score from the score for quality of life, perceived usefulness, perceived ease of use, and user control.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Schnall, PhD, MPH, RN-BC, FAAN, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAP1258
- R21HS023963 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV (Human Immunodeficiency Virus)
-
Merck Sharp & Dohme LLCWithdrawnHIV-1 | Immunodeficiency Virus Type 1, Human | Human Immunodeficiency Virus Type 1 | Human Immunodeficiency Virus 1
-
National Institute of Allergy and Infectious Diseases...CompletedHuman Immunodeficiency Virus (HIV) | Human Immunodeficiency Virus PreventionUnited States
-
RTI InternationalCenters for Disease Control and PreventionCompletedHuman Immunodeficiency Virus (HIV) PositiveUnited States
-
Bristol-Myers SquibbCompleted
-
Janssen-Cilag International NVCompletedHuman Immunodeficiency Virus (HIV) Infections | Acquired Immunodeficiency Syndrome (AIDS) VirusFrance, United Kingdom, Belgium, Germany, Spain, Switzerland, Denmark, Israel, Austria, Poland, Hungary, Sweden, Ireland
-
Merck Sharp & Dohme LLCRecruitingHuman Immunodeficiency Virus (HIV) InfectionUnited States, Mexico, Russian Federation, South Africa, Thailand
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York University and other collaboratorsCompletedHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityMinistry of Health, SwazilandCompleted
-
Bristol-Myers SquibbMedarexCompletedHuman Immunodeficiency Virus (HIV)United States
-
Tibotec, IncTibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USACompletedHuman Immunodeficiency Virus (HIV)United States, Puerto Rico
Clinical Trials on Health Management App with symptom strategies
-
Columbia UniversityNational Institute of Nursing Research (NINR)CompletedHIV (Human Immunodeficiency Virus) | AIDS (Acquired Immunodeficiency Syndrome)United States
-
Chinese University of Hong KongNot yet recruitingOncology | SurvivorshipHong Kong
-
University of California, San FranciscoMassachusetts General Hospital; Aga Khan University; University of Utah; Texas... and other collaboratorsCompletedAcquired Immunodeficiency Syndrome | HIVUnited States, Kenya, Puerto Rico, South Africa
-
The Hong Kong Polytechnic UniversityResearch Grants Council, Hong KongRecruitingMuscular Atrophy | Child With Cancer | Child With Cerebral Palsy | Child With Medical ComplexityHong Kong
-
Chinese University of Hong KongActive, not recruitingOncology | SurvivorshipHong Kong
-
Zhongshan People's Hospital, Guangdong, ChinaRecruitingPostoperative Complications | Telerehabilitation | Patient Reported Outcome Measures | Exercise Therapy | Lung Neoplasms, Non-Small Cell Lung CancerChina
-
Sakarya UniversityRecruitingHypothyroidism | Symptoms and Signs | Mobile Application | Digital Health | Symptom ManagementTurkey
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Enrolling by invitationObesity | NAFLD | m-HealthChina
-
Northumbria UniversityNewcastle University; Versus Arthritis; Teesside UniversityUnknownSjogren's SyndromeUnited Kingdom
-
Akdeniz UniversityNot yet recruitingNon-Hodgkin Lymphoma | Decision Support System