Study of SystemCHANGE-HIV

NCT01256814 | Completed

• 1 other identifier: SystemCHANGE-HIV
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV/AIDS; Adult; Behavioral Intervention; Sleep; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Sleep quantity and quality

  15 weeks

Secondary Outcomes (2)

• Physical Activity

  15 weeks

• Mental Wellness

  15 weeks

Study Arms (2)

Behaviorial Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

The control group will receive the manual "Symptom Management Manual: Strategies for People Living with HIV/AIDS".

Behavioral: SystemCHANGE-HIV

Interventions

SystemCHANGE-HIV BEHAVIORAL

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.

Behaviorial Intervention; Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Association of Nurses in AIDS Care: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (8)

• 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.

  PMID: 12867348 BACKGROUND

• 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.

  PMID: 18790317 BACKGROUND

• 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.

  PMID: 19265552 BACKGROUND

• 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.

  PMID: 20070207 BACKGROUND

• 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.

  PMID: 18677885 BACKGROUND

• 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.

  PMID: 11275275 BACKGROUND

• 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.

  PMID: 16472039 BACKGROUND

• 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.

  PMID: 12389268 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor and Clinical Research Scholar

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

US (1)