ClinicalTrials.gov
ClinicalTrials.gov Menu

Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01662336
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

August 8, 2012
August 10, 2012
June 19, 2017
January 29, 2018
January 29, 2018
June 2012
June 2016   (Final data collection date for primary outcome measure)
Percentage of Participants Adherent to Treatment at Month 6 [ Time Frame: Baseline and 6 months ]
Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
Adherence will be measured by the Adherence Self - Efficacy Scale (ASES) .The primary outcome measure of the current study will be adherence with KALETRA treatment at 6 months after enrollment in the KASA program. [ Time Frame: 6 months ]
The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen but also diet and exercise.
Complete list of historical versions of study NCT01662336 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Adherence Summative Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.
  • Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]

    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).

    The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy.

  • Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.
  • Percentage of Participants Adherent to Treatment at Month 12 [ Time Frame: Baseline and 12 months ]
    Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.
  • Change From Baseline in Health-related Quality of Life General Health Perception Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Role Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Social Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Pain Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Mental Health Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.
  • Change From Baseline in Patient Perception of Stress [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.
  • Change From Baseline in Psychological Well-being [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.
  • Change From Baseline in Coping Self-Efficacy [ Time Frame: Baseline, Month 6 and Month 12 ]
    Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.
  • Health Resource Utilization [ Time Frame: Baseline, Month 6 and Month 12 ]
    Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.
  • Viral Load at Each Visit [ Time Frame: Baseline, Month 6 and Month 12 ]
  • Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit [ Time Frame: Baseline, Month 6 and Month 12 ]
  • Healthcare Provider Satisfaction [ Time Frame: Month 6 and Month 12 ]
    For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.
  • Change in patient Quality of Life as measured by the QOL 601-2 (Health Status Assessment Questionnaire) [ Time Frame: From Month 0 to Month 12 ]
    The QOL 601-2 ("Health Status Assessment" ) survey is a brief, comprehensive measure of health-related quality of life used extensively in Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS).
  • Change in patient perception of stress as measured by the Perceived Stress Scale [ Time Frame: From 0 months to 12 months ]
    The Perceived Stress Sale is a 10-item questionnaire that assesses the degree to which the patient considers situations as stressful.
  • Change in psychological well-being as measured by the Center for Epidemiologic studies depression scale (CES-D) [ Time Frame: From 0 months to 12 months ]
    The CES-D is a 20-item questionnaire assessing the presence of depressive state during the previous week.
  • Change in Coping Self-Efficacy will be measured the change in the Coping Self - Efficacy Scale (CSE) [ Time Frame: From 0 months to 12 months ]
    CSE is a 13 item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges.
Not Provided
Not Provided
 
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.

The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.

This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients were enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV-positive patients.
Human Immunodeficiency Virus Infection
  • Drug: Lopinavir / ritonavir
    Prescribed according to the product monograph and physician's discretion.
    Other Names:
    • Kaletra®
    • LPV/r
  • Behavioral: Kaletra Adherence Support Assistance Program
    A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
    Other Name: KASA
Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Interventions:
  • Drug: Lopinavir / ritonavir
  • Behavioral: Kaletra Adherence Support Assistance Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
240
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is HIV-positive
  • On treatment with LPV/r or currently initiated on treatment with LPV/r.
  • Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
  • Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.
  • Prescribed LPV/r as part of his/her treatment by the treating physician.

Exclusion Criteria:

  • Not willing to sign an informed consent.
  • In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.
  • Is currently participating in a clinical trial of an investigational product.
  • Not willing to participate in the KASA program.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada
 
NCT01662336
P13-566
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Christina Pelizon, MD AbbVie Corporation
AbbVie
June 2017