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Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities (TEAMH)

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ClinicalTrials.gov Identifier: NCT03387397
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Frances R Wallach, Northwell Health

Brief Summary:
The investigators propose to utilize quantitative and qualitative methodology to better understand the impact of multiple drug use (polypharmacy) on medication adherence as well as the driving forces behind differential adherence in people living with HIV (PLWH) with comorbidities. Since the clinical relevance of differential adherence to antiretroviral therapy (ART) medication has already been demonstrated and associated with virologic failure and a more rapid progression to AIDS and death, it is imperative to understand the driving forces behind differential adherence (selective drug taking) and its impact on treatment outcomes in PLWH with comorbidities. Moreover, the use of technology to improve medication adherence is receiving much attention, and there are several smartphone applications that send medication reminders and generate personalized text messages to further motivate users. This type of technology could be particularly beneficial to patients who are managing multiple medications for multiple conditions. To this end, the investigators propose to use the medication adherence smartphone-based application, 'Technology for Engagement And Management of Health (TEAMH) to track both medication adherence and medication side effects in real-time among PLWH with comorbidities. TEAMH is an interactive health care information technology system that is not only patient-centered in that it encourages patient engagement in health care self-management, but also offers significant cost savings by directly connecting patients with their health care providers allowing providers to quickly address any health issue that may arise, thus potentially avoiding costly hospitalizations later on.

Condition or disease Intervention/treatment Phase
HIV Infection Primary Device: TEAMH App Not Applicable

Detailed Description:
TEAMH technology provides: 1) calendar-based medication reminders; 2) specific medication information tailored to each patient's medication regimen; 3) health education material; 4) direct contact with a health care provider through text messaging to discuss patients' symptoms and side effects and; 5) reminders for medical appointments as well as medication refills and laboratory testing. TEAMH provides a constant dialog between provider and patient through ongoing text messaging, allowing providers to regularly monitor patients' adherence to their medication regimen (data is transmitted directly to the providers) and to their medical appointments. Any number of medications can be included, making it ideal for HIV patients with comorbidities. In addition, TEAMH has the potential to interface with the Northwell Health (NH) electronic medical record (EMR) system allowing for the collection of comprehensive health information on each patient (e.g., lab results, medical appointments, hospitalizations) participating in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Intervention Model: Single Group Assignment
Intervention Model Description: quasi-experimental pretest and posttest study design.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
TEAMH program
The study includes one intervention arm and no control arm. All enrolled patients will be given the TEAMH smartphone application intervention for a period of 6 months. Enrolled patients will be grouped into two mutually exclusive cohorts according to the number of daily prescribed chronic medications (both ART and non-ART). Patients will be assigned to the Lower Medications (LM) cohort group (N=85) if they received a drug regimen of less than five different medications/day during the study period. Whereas, patients will be assigned to the Higher Medications (HM) cohort group (N=85) if they received a drug regimen of more than 5 different chronic medications/day during the study period.
Device: TEAMH App
Patients enrolled either use their own phone or will be provided with a smartphone loaded with the TEAMH app and content. TEAMH app will be used to: 1) monitor antiviral treatment adherence and adherence to non-HIV medications with reminders tailored to the patient's specific medication dosing schedule; 2) monitor compliance with HIV care medical appointments; 3) contact a health educator regarding medication side effect monitoring; 4) deliver HIV-infection and medication treatment related information; 5) monitor patients' symptoms and side effects. To this end, the health educator will conduct phone calls, as needed, to discuss patient symptoms and concerns and, 6) monitor adherence to clinical appointments.




Primary Outcome Measures :
  1. Self-reported adherence to antiretroviral therapy (ART) [ Time Frame: baseline and 6 months ]
    To measure medication adherence to ART we will use the validated AIDS Clinical Trials Group (ACTG) Adherence Questionnaire. This assessment is considered one of the "gold-standard" ART self-reported adherence questionnaires. The questionnaire assesses the number of doses missed per medication per day over a recall period of the previous four days. Mean number of doses missed is calculated for all ART medications over the four days. A higher mean, indicates more doses missed.


Secondary Outcome Measures :
  1. Quality of Life (QoL) [ Time Frame: Change from baseline QoL at six months ]
    We will use the World Health Organization HIV QoL Brief Scale (WHOQOL-HIV BREF) which is a widely used, validated scale to assess QoL indicators that are most relevant to PLWH. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. A higher score indicates greater quality of life.

  2. Patients' illness-specific symptoms and medication-specific side effects [ Time Frame: Change from patients' baseline illness-specific symptoms and medication-specific side effects at six months ]
    We will assess illness-specific symptoms and medication-specific side effects (MSSE using the HIV Symptom Index Questionnaire (HIV-SIQ). HIV-SIQ is a validated instrument that assesses a total of 20 symptoms on a 5-point Likert scale which also assesses symptom severity. A greater score indicates greater burden of symptoms.

  3. Patients' beliefs about medication's [ Time Frame: Change from patients' baseline beliefs about medication's at six months ]
    We will use the Beliefs about Medicines Questionnaire (BMQ) to assess patients' reasoning behind adherence or non-adherence. The BMQ comprises two sections: the BMQ-Specific (SpecificNecessity and Specific-Concerns; 10 items), that assesses beliefs about the medication prescribed for personal use, and the BMQ-General (General-Harm and General-Overuse; eight items), which assesses beliefs about medication in general. All items have a five-point Likert answer option, which varies from strongly agree to strongly disagree. Higher scores indicate stronger beliefs about the corresponding concepts in each sub-scale (ie, more negative beliefs about medicines).

  4. Patients' illness perception's [ Time Frame: Change from patients' baseline illness perception's at six months ]
    We will use the revised version of the Illness Perception Questionnaire (IPQ) to assess patients' own personal beliefs about their illnesses and their treatments, and their emotional responses towards the treatments. The IPQ was originally developed for cancer patients, but it has been revised to accommodate PLWH and other chronic conditions. Patients will complete the questionnaire in response to each of their chronic conditions (including HIV). The IPQ is a 5-point Likert scale questionnaire ranging from 1 (strongly agree) to 5 (strongly disagree). A higher schore indicates a more negative perception of a patient's illness.

  5. Patients' pill burden perceptions [ Time Frame: Baseline ]
    We will query patients regarding their perceptions of pill burden using the Pill Burden Questionnaire (PBQ). The PBQ, developed by Zhou et al.,19 consists of five questions with answers ranging from: 1) strongly agree; 2) disagree; 3) neither agree nor disagree. A high score indicates a higher perceived burden.

  6. Hospitalization rates [ Time Frame: change from 6 months prior to enrollment up to 6 months post enrollment ]
    We will use the electronic medical record (EMR) system, information from Healthix (the Regional Health Information Organization) and self-report to record hospital utilization (hospitalization rates). We will use a summed score of number of hospital visits during the study period.

  7. urgent care center rates [ Time Frame: change from 6 months prior to enrollment up to 6 months post enrollment ]
    We will use the electronic medical record (EMR) system, information from Healthix (the Regional Health Information Organization) and self-report to record hospital utilization (urgent care center visits). We will use a summed score of number of urgent care visits during the study period.

  8. Emergency Department visit rates [ Time Frame: change from 6 months prior to enrollment up to 6 months post enrollment ]
    We will use the electronic medical record (EMR) system, information from Healthix (the Regional Health Information Organization) and self-report to record hospital utilization (ED visits). We will use a summed score of number of ED visits during the study period.

  9. HIV viral load [ Time Frame: baseline and six months ]
    To assess the impact of our TEAMH app on medication adherence in PLWH with comorbidities we propose to test HIV Viral Load.

  10. CD4 (cluster of differentiation 4) T-cell counts [ Time Frame: baseline and six months ]
    To assess the impact of our TEAMH app on medication adherence in PLWH with comorbidities we propose to test CD4 T-cell counts.

  11. Medication adherence using the TEAMH smartphone application [ Time Frame: Change from baseline Medication adherence using the TEAMH smartphone application at 6 months. ]
    We will measure adherence using the smartphone application. It will calculate counts of daily doses taken and whether the medications were taken on time.

  12. Medication adherence using pharmacy refills to both ART and non-ART [ Time Frame: Change from Medication adherence using pharmacy refills to both ART and non-ART at 6 months ]
    To measure medication adherence using pharmacy refills we will use the proportion of days covered (PDC). PDC = number of days covered by prescription fills/number of days between the first prescription fills during the measurement period and the end of the measurement period (180 days).


Other Outcome Measures:
  1. Qualitative Measures for Focus Group [ Time Frame: End of enrollment period ( 6 months) ]
    Focus Groups -Two focus groups will be conducted to understand the driving forces behind differential adherence and to understand the impact of number of chronic medications on differential adherence. Group 1 will include 10 patients that are in the low medication group taking less than 5 medications. Group 2 will consist of 10 patients taking more than 5 medications (high medication group)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

All patients must:

  • be HIV infected
  • be English speaking
  • be 18 years or older
  • have at least one comorbidity requiring, at least, one additional chronic medication (defined as a medication that the person needs to be taking for at least six months).

Exclusion Criteria

  • Evidence of cognitive impairment that limits the ability to complete the intervention
  • Terminally ill patients will be also excluded.

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): NCT03387397


Contacts
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Contact: Frances R Wallach, MD 516-562-4280 fwallach@northwell.edu
Contact: Rebecca Schwartz, Ph.D 516-465-7926 Rschwartz3@northwell.edu

Locations
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United States, New York
Center for AIDS Research and Treatment Recruiting
Manhasset, New York, United States, 11030
Contact: Stephanie Augustine, RN    516-562-3361    saugustine@northwell.edu   
Sub-Investigator: Joseph McGowan, MD         
Sponsors and Collaborators
Northwell Health
Gilead Sciences
Investigators
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Principal Investigator: Frances R Wallach, MD Northwell Health

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Responsible Party: Frances R Wallach, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03387397     History of Changes
Other Study ID Numbers: 17-0063
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frances R Wallach, Northwell Health:
Co-morbidities

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases