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

2019년 11월 21일 업데이트: 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.

연구 개요

상태

알려지지 않은

상세 설명

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.

연구 유형

중재적

등록 (예상)

420

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Quebec
      • Montreal, Quebec, 캐나다
        • CHUM

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

35년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
간섭 없음: No Dashboard group
The control group will receive only the goal-setting instructions and tips.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Goal specificity
기간: "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
기간: "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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2019년 12월 1일

기본 완료 (예상)

2020년 2월 1일

연구 완료 (예상)

2020년 3월 1일

연구 등록 날짜

최초 제출

2019년 11월 19일

QC 기준을 충족하는 최초 제출

2019년 11월 21일

처음 게시됨 (실제)

2019년 11월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 11월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 11월 21일

마지막으로 확인됨

2019년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ABHN_Goals

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 질환에 대한 임상 시험

My Personal Brain Health Dashboard에 대한 임상 시험

3
구독하다