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

21 novembre 2019 aggiornato da: Nancy Mayo, McGill University

Effectiveness of a Personalized Health Profile on Specificity of Self-Management Goals Among People Living With HIV in Canada: A Blinded Pragmatic Randomized Controlled Trial

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.

Panoramica dello studio

Stato

Sconosciuto

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

420

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Quebec
      • Montreal, Quebec, Canada
        • CHUM

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

35 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

This study is a sub-study under the BHN trial. Eligibility criteria for the main BHN trial includes:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dashboard group
The intervention group will receive their personal profile via this e-mail along with instructions on goal-setting and tips to improve brain health.
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.
Nessun intervento: No Dashboard group
The control group will receive only the goal-setting instructions and tips.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Goal specificity
Lasso di tempo: "4 weeks" in total for each participant
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
Lasso di tempo: "4 weeks" in total for each participant
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 dicembre 2019

Completamento primario (Anticipato)

1 febbraio 2020

Completamento dello studio (Anticipato)

1 marzo 2020

Date di iscrizione allo studio

Primo inviato

19 novembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

21 novembre 2019

Primo Inserito (Effettivo)

25 novembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 novembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 novembre 2019

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ABHN_Goals

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su My Personal Brain Health Dashboard

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