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Goal-Management Training for HIV
N/A
Waitlist Available
Led By Nancy Mayo, PhD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 and 12 months
Awards & highlights
Study Summary
This trial will test whether goal management training can help people with HIV better adhere to health recommendations and achieve health-related goals, leading to better brain and overall health outcomes.
Who is the study for?
This trial is for individuals who have been living with HIV for at least a year, can consent in French or English, and show signs of cognitive frailty or don't meet 'successful aging' criteria. It's not suitable for those unable to do moderate exercise, with a life expectancy under 3 years, active brain infections, hepatitis C needing treatment during the study, dementia affecting cognition, other neurological disorders impacting thinking skills, psychosis or recent substance abuse.Check my eligibility
What is being tested?
The trial tests if adding Goal Management Training (GMT) to a Healthy Lifestyle Program (HLP) leads to better adherence to health recommendations and outcomes than the HLP alone. Participants will be randomly assigned either GMT plus HLP or just HLP and their brain health and general health outcomes will be compared.See study design
What are the potential side effects?
Since this trial involves goal-setting training and lifestyle changes rather than medication, side effects are minimal but may include potential stress from lifestyle adjustments or discomfort from increased physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in physical activity
Change in social activity
Secondary outcome measures
Change in anxiety
Change in depression
Change in distress
+7 moreOther outcome measures
Change in Cardiovascular Risk Score
Change in cognitive performance
Change in energy/fatigue
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GMT Intervention + Health Lifestyle ProgramExperimental Treatment1 Intervention
The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual and which consists of 9 sessions each 2-hours in duration. They will also participate in the Healthy Lifestyle Program (HLP), which includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.
Group II: Health Lifestyle ProgramActive Control1 Intervention
The control group enters directly into the HLP without any other study visits. The HLP includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.
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Who is running the clinical trial?
McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,281 Total Patients Enrolled
Nancy Mayo, PhDPrincipal InvestigatorMcGill University
5 Previous Clinical Trials
407 Total Patients Enrolled
Lesley Fellows, PhD/MDPrincipal InvestigatorMcGill University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced dementia.I do not have an active brain infection or hepatitis C needing treatment.I can communicate well in either French or English.I have a brain condition not related to HIV that could affect my thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Health Lifestyle Program
- Group 2: GMT Intervention + Health Lifestyle Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being accepted for this clinical experiment?
"According to clinicaltrials.gov, this trial has suspended recruitment; the project was first published on July 1st 2020 and most recently modified on April 10th 2020. As of present, 83 other trials are actively recruiting candidates across various locations."
Answered by AI
What outcomes is the clinical trial seeking to ascertain?
"Evaluating over a 0 and 12 month period, the primary outcome of this medical trial is to ascertain any Change in social activity. Secondary objectives include measuring alterations in distress (Visual Analogue Health States - min score: 0; max score: 10), physical Activity pattern (Garmin vívofit 4 Activity Tracker - daily step counts/time spent at various cadences/sitting time), as well as general health perception (Visual Analogue Health States)."
Answered by AI
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