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CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

Primary Purpose

HIV, Stress Disorder, Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBSM-SMI
CBSM-SMI control
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Self-Management, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive
  • Reads and understands English
  • Scores greater than 5 on the HIV-Related Fatigue Scale
  • Mentally competent to give informed consent

Exclusion Criteria:

  • Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis)
  • Pregnant women and women who are less than 1 year postpartum
  • Active psychosis or dementia
  • Suicidal ideation with clear intent
  • Current substance dependence

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBSM-SMI

CBSM-SMI control

Arm Description

The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.

The control group will receive an app called LifeSum, which focuses on healthy lifestyles.

Outcomes

Primary Outcome Measures

Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Feasibility and Acceptability Scale
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.

Secondary Outcome Measures

HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
HIV-Related Fatigue Scale (HRFS)
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
PROMIS Short Form - Fatigue 8a
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
PROMIS Short Form - Fatigue 8a
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
PROMIS Short Form - Fatigue 8a
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
PROMIS Short Form - Fatigue 8a
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
The State Trait Anxiety Inventory (STAI)-State
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
The State Trait Anxiety Inventory (STAI)-State
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
The State Trait Anxiety Inventory (STAI)-State
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
The State Trait Anxiety Inventory (STAI)-State
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory (BDI-II)
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Life Experiences Scale
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
CD4 count from the medical record
A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.
CD4 count from the medical record
A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.
HIV viral load information from the medical record
A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.
HIV viral load information from the medical record
A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.

Full Information

First Posted
May 4, 2017
Last Updated
July 17, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03149094
Brief Title
CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue
Official Title
Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.
Detailed Description
For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Stress Disorder, Human Immunodeficiency Virus, Fatigue
Keywords
Self-Management, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBSM-SMI
Arm Type
Experimental
Arm Description
The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
Arm Title
CBSM-SMI control
Arm Type
Active Comparator
Arm Description
The control group will receive an app called LifeSum, which focuses on healthy lifestyles.
Intervention Type
Behavioral
Intervention Name(s)
CBSM-SMI
Intervention Description
The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
Intervention Type
Behavioral
Intervention Name(s)
CBSM-SMI control
Intervention Description
this group will receive the LifeSum app.
Primary Outcome Measure Information:
Title
Feasibility and Acceptability Scale
Description
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time Frame
Baseline
Title
Feasibility and Acceptability Scale
Description
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time Frame
10 weeks
Title
Feasibility and Acceptability Scale
Description
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
HIV-Related Fatigue Scale (HRFS)
Description
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time Frame
Baseline
Title
HIV-Related Fatigue Scale (HRFS)
Description
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time Frame
5 weeks
Title
HIV-Related Fatigue Scale (HRFS)
Description
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time Frame
10 weeks
Title
HIV-Related Fatigue Scale (HRFS)
Description
The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.
Time Frame
22 weeks
Title
PROMIS Short Form - Fatigue 8a
Description
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
Time Frame
Baseline
Title
PROMIS Short Form - Fatigue 8a
Description
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
Time Frame
5 weeks
Title
PROMIS Short Form - Fatigue 8a
Description
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
Time Frame
10 weeks
Title
PROMIS Short Form - Fatigue 8a
Description
The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role.
Time Frame
22 weeks
Title
The State Trait Anxiety Inventory (STAI)-State
Description
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
Time Frame
Baseline
Title
The State Trait Anxiety Inventory (STAI)-State
Description
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
Time Frame
5 weeks
Title
The State Trait Anxiety Inventory (STAI)-State
Description
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
Time Frame
10 weeks
Title
The State Trait Anxiety Inventory (STAI)-State
Description
The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.
Time Frame
22 weeks
Title
Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
Baseline
Title
Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
5 weeks
Title
Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
10 weeks
Title
Beck Depression Inventory (BDI-II)
Description
The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
22 weeks
Title
Life Experiences Scale
Description
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time Frame
Baseline
Title
Life Experiences Scale
Description
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time Frame
5 weeks
Title
Life Experiences Scale
Description
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time Frame
10 weeks
Title
Life Experiences Scale
Description
The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.
Time Frame
22 weeks
Title
CD4 count from the medical record
Description
A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.
Time Frame
Baseline
Title
CD4 count from the medical record
Description
A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.
Time Frame
22 weeks
Title
HIV viral load information from the medical record
Description
A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.
Time Frame
Baseline
Title
HIV viral load information from the medical record
Description
A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV positive Reads and understands English Scores greater than 5 on the HIV-Related Fatigue Scale Mentally competent to give informed consent Exclusion Criteria: Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis) Pregnant women and women who are less than 1 year postpartum Active psychosis or dementia Suicidal ideation with clear intent Current substance dependence
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31539601
Citation
Barroso J, Madisetti M, Mueller M. A Feasibility Study to Develop and Test a Cognitive Behavioral Stress Management Mobile Health Application for HIV-Related Fatigue. J Pain Symptom Manage. 2020 Feb;59(2):242-253. doi: 10.1016/j.jpainsymman.2019.09.009. Epub 2019 Sep 17.
Results Reference
derived

Learn more about this trial

CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue

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