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An Automated, Tailored Information Application for Medication Health Literacy

Primary Purpose

Human Immunodeficiency Virus I Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Information
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus I Infection focused on measuring Health literacy, HIV, Medication Adherence, IMB Model

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 years or older
  • Currently treated with at least one medication for HIV infection
  • No change in target medication anticipated in the next two months
  • Able to participate in the study intervention in English

Exclusion Criteria:

  • Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
  • Not able to participate in the intervention using English.

Sites / Locations

  • Ziff Health Clinics, Nova Southeastern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailored Information

Arm Description

Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection.

Outcomes

Primary Outcome Measures

Medication adherence
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.

Secondary Outcome Measures

Participant self-efficacy
Mood
Elements of the Information, Motivation, and Behavioral Skills Model
A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
Intervention acceptability and usability
A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.

Full Information

First Posted
February 18, 2011
Last Updated
February 28, 2013
Sponsor
Nova Southeastern University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01304186
Brief Title
An Automated, Tailored Information Application for Medication Health Literacy
Official Title
An Automated, Tailored Information Application for Medication Health Literacy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.
Detailed Description
Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus I Infection
Keywords
Health literacy, HIV, Medication Adherence, IMB Model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Information
Arm Type
Experimental
Arm Description
Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Information
Other Intervention Name(s)
Health literacy
Intervention Description
The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
Primary Outcome Measure Information:
Title
Medication adherence
Description
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.
Time Frame
Four weeks after intervention
Secondary Outcome Measure Information:
Title
Participant self-efficacy
Time Frame
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Title
Mood
Time Frame
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Title
Elements of the Information, Motivation, and Behavioral Skills Model
Description
A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
Time Frame
Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Title
Intervention acceptability and usability
Description
A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.
Time Frame
Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Currently treated with at least one medication for HIV infection No change in target medication anticipated in the next two months Able to participate in the study intervention in English Exclusion Criteria: Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent. Not able to participate in the intervention using English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziff Health Clinics, Nova Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23293544
Citation
Ownby RL, Waldrop-Valverde D, Caballero J, Jacobs RJ. Baseline medication adherence and response to an electronically delivered health literacy intervention targeting adherence. Neurobehav HIV Med. 2012 Oct 18;4:113-121. doi: 10.2147/NBHIV.S36549.
Results Reference
result
PubMed Identifier
22961499
Citation
Ownby RL, Waldrop-Valverde D, Hardigan P, Caballero J, Jacobs R, Acevedo A. Development and validation of a brief computer-administered HIV-Related Health Literacy Scale (HIV-HL). AIDS Behav. 2013 Feb;17(2):710-8. doi: 10.1007/s10461-012-0301-3.
Results Reference
result
PubMed Identifier
23446180
Citation
Ownby RL, Waldrop-Valverde D, Jacobs RJ, Acevedo A, Caballero J. Cost effectiveness of a computer-delivered intervention to improve HIV medication adherence. BMC Med Inform Decis Mak. 2013 Feb 28;13:29. doi: 10.1186/1472-6947-13-29.
Results Reference
derived

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An Automated, Tailored Information Application for Medication Health Literacy

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