Study of SystemCHANGE-HIV
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ClinicalTrials.gov Identifier: NCT01256814 |
Recruitment Status
:
Completed
First Posted
: December 9, 2010
Last Update Posted
: August 30, 2011
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Condition or disease | Intervention/treatment | Phase |
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HIV | Behavioral: SystemCHANGE-HIV | Not Applicable |
Sample: The study sample will include 40 HIV+ men and women. Inclusion criteria include: a documented HIV diagnosis; adult (18 years old or greater); and English speaking.
Design: The SystemCHANGE-HIV study will be a 15-week, randomized, two-group experimental design including a 10-week behavioral intervention. In the experimental group, one half of the participants (n=20) will receive the intervention; and in the control group, the other half of the participants will undergo usual care. Both the experimental and control group will complete the same psychometric instrument packet, three times, to give a comparison of self-management before and after intervention and at a four-week follow up visit. This packet includes information on medical history, demographics, HIV self-management,physical activity, social support, social capital, mental wellness, and quality of life.Additionally, all participants will wear an actigraph for seven consecutive days, at each data collection point, to assess sleep.
Analysis:Preliminary data analysis will include descriptive statistics and scatter plots to examine the distribution of each outcome at each time point, as well as each covariate of interest. Although our randomization scheme will ensure balance of baseline variables between the two arms (other than that due to chance alone), we will estimate the standardized magnitude of each baseline difference as well as the correlation between each baseline variable and each outcome of interest at 10 weeks or at 15 weeks to objectively determine baseline variables that will be needed to estimate the unbiased effect of the intervention on each outcome. The primary analysis will be based on intent to treat approach and will investigate the effect of the intervention on continuous outcomes at 10 weeks or 15 weeks. In particular, an Analysis of Covariance model will be used that adjusts for treatment arm and the baseline level of the outcome variable. Such a model will allow us to estimate the effect of the intervention on each outcome, adjusting for the baseline outcome.In addition, linear mixed models will be used to determine if the effect of the intervention on the outcome at 10 weeks differs from the effect of the intervention on the outcome at 15 weeks. If needed, all analyses will be repeated using an as-treated approach. All analyses will be performed using a two-sided significance of 0.05.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | SystemCHANGE-HIV: A Pilot Study Exploring the Effect of a Systems-based Intervention to Increase Physical Activity, Sleep Behavior, and Mental Wellness |
Study Start Date : | January 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
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Experimental: Behaviorial Intervention
SystemCHANGE-HIV is a 10-week, small-group intervention that will promote behavior changes to improve the following: physical activity, sleep behaviors and mental wellness. S
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Behavioral: SystemCHANGE-HIV
SystemCHANGE, is based on social ecological theory and focuses on redesigning the family environment and daily routines that are linked to health behavior. This framework emphasizes context and specifies that change is best accomplished by: identifying a measurable goal, examining the system processes surrounding attainment of that goal, listing several ideas that may improve the system, engaging in a series of experiments to test the best ideas to improve the process, implementing the most successful ideas based on data from the experiments, and monitoring the system to maintain the gains. The SystemCHANGE-HIV intervention works to help participants make small environmental changes made in family daily routines that will eventually construct an environment.
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Active Comparator: Control
The control group will receive the manual "Symptom Management Manual: Strategies for People Living with HIV/AIDS".
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Behavioral: SystemCHANGE-HIV
SystemCHANGE, is based on social ecological theory and focuses on redesigning the family environment and daily routines that are linked to health behavior. This framework emphasizes context and specifies that change is best accomplished by: identifying a measurable goal, examining the system processes surrounding attainment of that goal, listing several ideas that may improve the system, engaging in a series of experiments to test the best ideas to improve the process, implementing the most successful ideas based on data from the experiments, and monitoring the system to maintain the gains. The SystemCHANGE-HIV intervention works to help participants make small environmental changes made in family daily routines that will eventually construct an environment.
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- Sleep quantity and quality [ Time Frame: 15 weeks ]
- Physical Activity [ Time Frame: 15 weeks ]
- Mental Wellness [ Time Frame: 15 weeks ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- documented HIV diagnosis
- adult (21 years old or greater)
- English speaking
Exclusion Criteria:

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): NCT01256814
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 |
Publications:
Responsible Party: | Allison Webel, Instructor and Clinical Research Scholar, Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT01256814 History of Changes |
Other Study ID Numbers: |
SystemCHANGE-HIV |
First Posted: | December 9, 2010 Key Record Dates |
Last Update Posted: | August 30, 2011 |
Last Verified: | August 2011 |
Keywords provided by Allison Webel, Case Western Reserve University:
HIV/AIDS Adult Behavioral Intervention Sleep Physical Activity |