Effectiveness of a Personalized Health Profile on Specificity of Self-Management Goals

NCT04175795 | Unknown

• 1 other identifier: ABHN_Goals
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

With a growing number of people living with chronic diseases, the need to empower people for self-management is rising. A key element in self-management is goal setting but the extent to which meaningful actionable goals (i.e., SMART) can be set without direction from the health care team is not known. Providing people with specific feedback on actionable health outcomes may stimulate the setting of specific goals. To this end, a health outcome profile was computer generated from the existing outcome measures, at first and last recorded visits, of each person enrolled in the Positive Brain Health Now (+BHN) cohort from 5 sites in Canada. This profile will be tested with BHN participants who agreed to enrolled in sub-studies. The main outcome will be the extent to which goals are SMART by using specific words and actionable verbs. A measurement framework and an initial lexical (i.e., collection of vocabularies) has been developed for the goal evaluation. Using text mining techniques (i.e., tokenizing and pos-tagging), the specific components of each goal will be extracted and compared to the lexical using regular expression algorithms. The result will provide information on the specificity of participants' defined goals.

Conditions

Chronic Disease; Goals

Keywords

Goal-setting; Goal specificity; Chronic conditions; Health outcome profile

Outcome Measures

Primary Outcomes (2)

• Goal specificity

  The main outcome in this study is the specificity of self-management goals. For goal specificity, text mining techniques will be used. This outcome will be reported as a time-independent discrete variable - number of specific words (matched to a developed lexical) per person-goals.

  "4 weeks" in total for each participant

• Number of self-management goals

  For this outcome number of goals per person as well as total number of goals per group will be reported.

  "4 weeks" in total for each participant

Study Arms (2)

Dashboard group

EXPERIMENTAL

The intervention group will receive their personal profile via this e-mail along with instructions on goal-setting and tips to improve brain health.

Behavioral: My Personal Brain Health Dashboard

No Dashboard group

NO INTERVENTION

The control group will receive only the goal-setting instructions and tips.

Interventions

My Personal Brain Health Dashboard BEHAVIORAL

The intervention of this study is grounded in the knowledge-to-action framework (Graham et al., 2006) and consists of providing feedback by sending participants their personalized health outcome profiles. As mentioned above, the context of our study is the BHN cohort. For all participants enrolled in the parent study, data on wide spectrum of health outcomes have been gathered. As part of the knowledge translation plan, a personalized profile of specific modifiable health outcomes called as "My Personalized Brain Health Profile" has been created for each participant (Appendix B). The profile covers information on brain health outcomes, health and quality of life ratings, and lifestyle factors.

Dashboard group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults age ≥ 35 who have been diagnosed as HIV positive for at least one year, - able to communicate adequately in French or English,
• and able to give an informed consent

You may not qualify if:

• dementia,
• life expectancy of \<3 years or other,
• non-HIV-related neurological disorder,
• known active central nervous system opportunistic infection or hepatitis C requiring Interferon treatment,
• known Psychotic disorder,
• current (within the past 12 months) substance dependence or abuse.

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maryam Mozafarinia, PhD student

CONTACT

(438) 990-1805; maryam.mozafarinia@mail.mcgill.ca

Dr. Nancy Mayo

CONTACT

(514) 934-1934; nancy.mayo@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James mcGill Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)