- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03034993
Self-Management Using Text Messaging in a Homeless Population
Improving Self-Management of Chronic Conditions Among Homeless Persons: a Community-Based Participatory Approach Using Text Messaging
연구 개요
상세 설명
Boston Healthcare for the Homeless Program (BHCHP) is the study site for this research. It is the largest freestanding health care for the homeless program in the country - it provides primary care, behavioral health, oral health care and other wrap-around services to 12,500 homeless individuals a year. BHCHP was recently awarded a two-year grant from the Massachusetts Health Policy Commission to demonstrate how intensive, coordinated case management can reduce costs of caring for homeless persons who are high utilizers of emergency department (ED) and inpatient care. The Social Determinants of Health Coordinated Care Hub for Homeless Adults project (hereafter the "Care Hub") will create capacity among 9 Boston organizations serving homeless residents to meet their needs in primary care, behavioral health, housing, and shelter. This will improve quality of life, health outcomes, and care efficiency for the organizations. The participating organizations, in addition to BHCHP, are Bay Cove Human Services, Boston Public Health Commission, Boston Rescue Mission, Casa Esperanza, Massachusetts Housing and Shelter Alliance, The New England Center and Home for Veterans, St. Francis House, Victory Programs Specifically the investigators anticipate that patients participating in the Care Hub will have reduced use of ED and inpatient care because they will be better linked to and retained in appropriate care such as outpatient, mental health, substance use disorder (SUD), preventive care, and respite care. Regular care will increase the appropriate management of chronic health conditions and reduce episodes of exacerbations of these conditions which often lead to ED and hospital care. The purpose of this study is to evaluate whether an a text messaging system of appointment reminders, along with medication taking messages, and text messages about mood will augment the effectiveness of the Care Hub program.
The investigators propose to pilot a cell phone-based outpatient care support and medication reminder system. The content will include appointment reminders and educational and motivational messages about the importance of going to all outpatient care visits and of taking medications. The investigators take a community-based participatory research approach to this study - both because it appropriately considers the needs of the target population (increasing the likelihood of success) and because it empowers a population that is often treated as if its members were powerless. The cell phone texting intervention will help patients stay engaged in care, adhere to their medications, and adopt and sustain behavior change. This will be accomplished by completing a series of objectives:
- To develop a text messaging system designed for homeless patients which includes appointment reminders, medication taking reminders and motivation, and texts messages that allow participants to report their mood, all in support of chronic disease management. The system will be based on a health coaching model, and message content will be reviewed and edited by patients who are members of drafted by patient members of a BHCHP Community Innovation Panel (CIP).
- To train Care Hub intervention patients (or refresh existing skills) in cell phone text messaging.
- To test the text messaging system in a randomized pilot study with 60 patients, comparing outpatient, respite care, ED, and inpatient utilization, and Health-Related Quality of Care (HRQOL) between the 30 intervention and 30 control patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
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Boston, Massachusetts, 미국, 02118
- Boston University School of Public Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- is a patient participant in the Coordinated Care Hub Initiative
- is willing to receive text messages
- is able to understand English - spoken and read
Exclusion Criteria:
- has an inability to find, open, and respond to a test text message
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Text Messaging
This group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood.
|
Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic.
The text message will indicate the time of the appointment and the location (e.g.
"Remember appointment Friday March 15 at 10am in the Yawkey building").
Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date.
Medication related texts will be sent every other day and will be educational and motivational (e.g.
"Keep taking medications that way the doctor prescribed them, even if feeling fine").
Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale.
The participant will text back a response.
|
|
위약 비교기: Control
This group will receive simple text messages about general health promotion, such as about the importance of drinking water on hot days, using sunscreen, etc.
|
Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic.
The text message will indicate the time of the appointment and the location (e.g.
"Remember appointment Friday March 15 at 10am in the Yawkey building").
Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date.
Medication related texts will be sent every other day and will be educational and motivational (e.g.
"Keep taking medications that way the doctor prescribed them, even if feeling fine").
Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale.
The participant will text back a response.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Emergency Department Visits Made
기간: 4 months
|
Data from BHCHP's electronic medical record (EMR) and from the Coordinated Care Hub electronic case management system in use by the Care Hub organizations, which includes admission and discharge data
|
4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Inpatient admissions
기간: 4 months
|
Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system
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4 months
|
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Appointment keeping
기간: 4 months
|
Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g.
0-100%).
|
4 months
|
|
Medication Adherence
기간: 4 months
|
Self report medication adherence is assessed with 2 measures: Morisky adherence scale, (range, 0=poor to 11=excellent) and a 1-item rating question in which patients rate their ability to take all their medications as prescribed (range, 1=very poor to 6=excellent)
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4 months
|
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Adult Well-Being Assessment
기간: 4 months
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This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.
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4 months
|
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Comfort with Computers and Cell Phones
기간: 4 months
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The eHealth Literacy Scale, eHEALS, (range 8-40, higher equals greater self-efficacy) assesses comfort with computers and the Internet for health related purposes.
Investigators will also adapt eHEALS so that separate items can be asked about comfort with cell phone use.
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4 months
|
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Frequency of Cell Phone Use and Computer Use
기간: 4 months
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Measures come from the Health Information National Trends Survey (HINTS).
Scale ranges from 0 (no use) to 12 (frequent use of many features).
|
4 months
|
|
Outpatient appointments
기간: 4 months
|
Number of outpatient visits made
|
4 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Donald K McInnes, ScD, Boston University and Department of Veterans Affairs
간행물 및 유용한 링크
일반 간행물
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- Larimer ME, Malone DK, Garner MD, Atkins DC, Burlingham B, Lonczak HS, Tanzer K, Ginzler J, Clifasefi SL, Hobson WG, Marlatt GA. Health care and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA. 2009 Apr 1;301(13):1349-57. doi: 10.1001/jama.2009.414.
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- Lee SS, August GJ, Gewirtz AH, Klimes-Dougan B, Bloomquist ML, Realmuto GM. Identifying unmet mental health needs in children of formerly homeless mothers living in a supportive housing community sector of care. J Abnorm Child Psychol. 2010 Apr;38(3):421-32. doi: 10.1007/s10802-009-9378-1.
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연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H-35967
- catalyst grant (기타 식별자: BU SPH)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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