Study of SystemCHANGE-HIV

SystemCHANGE-HIV: A Pilot Study Exploring the Effect of a Systems-based Intervention to Increase Physical Activity, Sleep Behavior, and Mental Wellness

The purpose of this study is to assess a new behavioral intervention to help how people living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new educational intervention can improve physical activity, sleep, mental wellness and quality of life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that those who are in the intervention group will practice more self-management skills than those in the control group.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: SystemCHANGE-HIV

Detailed Description

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
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• documented HIV diagnosis
• adult (21 years old or greater)
• English speaking

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
Active Comparator: Control; The control group will receive the manual "Symptom Management Manual: Strategies for People Living with HIV/AIDS".	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sleep quantity and quality	15 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Physical Activity	15 weeks
Mental Wellness	15 weeks

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: Association of Nurses in AIDS Care

Publications and helpful links

General Publications

• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
• Jean-Louis G, Kripke DF, Mason WJ, Elliott JA, Youngstedt SD. Sleep estimation from wrist movement quantified by different actigraphic modalities. J Neurosci Methods. 2001 Feb 15;105(2):185-91. doi: 10.1016/s0165-0270(00)00364-2.
• Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
• Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
• Beaglehole R, Epping-Jordan J, Patel V, Chopra M, Ebrahim S, Kidd M, Haines A. Improving the prevention and management of chronic disease in low-income and middle-income countries: a priority for primary health care. Lancet. 2008 Sep 13;372(9642):940-9. doi: 10.1016/S0140-6736(08)61404-X.
• Burton NW, Haynes M, Wilson LA, Giles-Corti B, Oldenburg BF, Brown WJ, Giskes K, Turrell G. HABITAT: A longitudinal multilevel study of physical activity change in mid-aged adults. BMC Public Health. 2009 Mar 5;9:76. doi: 10.1186/1471-2458-9-76.
• Kok G, Gottlieb NH, Commers M, Smerecnik C. The ecological approach in health promotion programs: a decade later. Am J Health Promot. 2008 Jul-Aug;22(6):437-42. doi: 10.4278/ajhp.22.6.437.
• Moore SM, Charvat JM. Using the CHANGE intervention to enhance long-term exercise. Nurs Clin North Am. 2002 Jun;37(2):273-83, vi-vii. doi: 10.1016/s0029-6465(01)00008-1.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Physical Activity; Sleep; Adult; Behavioral Intervention; HIV/AIDS
• Other Study ID Numbers: SystemCHANGE-HIV