Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Disease
  • Goals
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A blinded, stratified, randomized, controlled trial design will be used to assess the impact of the personalized health profile on number and specificity of person-defined self-management goals. All participants in the BHN2 cohort will be randomized into one of two groups, the intervention and control group. Participants will be stratified based on gender and number of visits (i.e., whether 1 visit or 2 visits) they had or will attend. Randomization will be done through the computer by the study statistician using randomization.com. All participants enrolled in the parent trial (BHN1) have a numerical ID. The new participants who will be recruited for the BHN2 will be enumerated and then the numbers will be randomized.Masking: Double (Investigator, Outcomes Assessor)Masking Description: For this study, it will not be possible to blind the participants as the intervention is their personalized health profile. To avoid bias in measure, those collecting and analyzing the data will be kept blind to group assignment.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 35 years and 125 years
Gender
Both males and females

Description

Introduction: With a growing number of people living with chronic diseases, the need to empower people to self-manage their condition is rising. A key element in self-management is goal setting, however, it is not known to what extent people living with chronic conditions are capable of setting thei...

Introduction: With a growing number of people living with chronic diseases, the need to empower people to self-manage their condition is rising. A key element in self-management is goal setting, however, it is not known to what extent people living with chronic conditions are capable of setting their own actionable health-related goals. One possible strategy to improve goal-setting skills is to provide people with specific information about their health profile to stimulate the setting of specific goals. This study contributes to the understanding of the specificity of patient-formulated self-management goals by testing the effectiveness of providing feedback using a personalized health outcome profile. Objective: To estimate among people living with HIV, to what extent providing feedback on their health outcomes, compared to no feedback, will affect number and specificity of person-defined self-management goals. Design: A blinded, stratified, randomized controlled trial design will be conducted targeting all participants in the BHN2 (Action for Positive Brain Health Now) cohort in Canada. Methods: A personalized health outcome profile has been produced for each person enrolled in the BHN1 cohort (Positive Brain Health Now) at cohort entry and at the last recorded visit. The same profile will be developed for the participants who will enroll in the BHN2 as they go through their visits. The profile covers information on brain health outcomes, health and quality of life ratings, and lifestyle factors. Participants from the BHN1 who agreed to enroll in the BHN2 as well as the new participants will be contacted. The intervention group will receive their personal profile along with instructions on goal-setting and tips to improve brain health; the control group will receive only the goal-setting instructions and tips. Over 800 members of the BHN cohort have sufficient data to generate the profile and will be recruited into the study. Persons will be instructed to enter their goals on a specialized web-based goal setting platform within 2 weeks of receiving their profile. At the close of the two-week period, the control group will receive their profile. Text mining techniques will be used to extract information from the person-defined goals and the specificity of the goal will be scored based on word matches to a developed goal-setting lexical. Expected Results: The expectation is that the intervention group will set more goals and have more words matching the developed lexical than the control group. The total number of words per person-goal will be calculated for each group and Poisson regression will be used to estimate the rate ratio and 95% confidence intervals and compare rate ratios between men and women using an interaction term. Conclusion: The effect of providing outcome feedback on setting effective self-management goals will be tested in this study. The results will provide a thorough understanding of the quality of person-defined goals using text mining. Moreover, this study provides evidence necessary for future studies using text mining as an inexpensive and timely way for evaluation of textual information.

Tracking Information

NCT #
NCT04175795
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • CIHR Canadian HIV Trials Network
Investigators
Not Provided