An Automated, Tailored Information Application for Medication Health Literacy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01304186
First received: February 18, 2011
Last updated: February 28, 2013
Last verified: February 2013

February 18, 2011
February 28, 2013
June 2010
November 2011   (final data collection date for primary outcome measure)
Medication adherence [ Time Frame: Four weeks after intervention ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01304186 on ClinicalTrials.gov Archive Site
  • Participant self-efficacy [ Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
  • Elements of the Information, Motivation, and Behavioral Skills Model [ Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
    A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.
Same as current
Not Provided
Not Provided
 
An Automated, Tailored Information Application for Medication Health Literacy
An Automated, Tailored Information Application for Medication Health Literacy

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus I Infection
Behavioral: Tailored Information
The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
Other Name: Health literacy
Experimental: Tailored Information
Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection.
Intervention: Behavioral: Tailored Information

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
June 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01304186
R21MH086491, R21MH086491
No
Nova Southeastern University
Nova Southeastern University
National Institute of Mental Health (NIMH)
Principal Investigator: Raymond L Ownby, MD, PhD Nova Southeastern University
Nova Southeastern University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP