- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02765542
Developing Accessible mHealth Programs for Depression Management in Bolivia
연구 개요
상세 설명
All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present.
In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.
The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
La Paz, 볼리비아
- El Servicio Departmental de Salud (SEDES) affiliated clinics
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 21-80 years of age
- PHQ-8 score of 10 or higher
Exclusion Criteria:
- Have diagnoses indicating a six-month life expectancy
- Prior inpatient psychiatric treatment
- Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Automated phone calls
Automated disease assessment & self-care support phone calls for up to 12 weeks.
|
Automated disease assessment & self-care support phone calls for up to 12 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
기간: Baseline and 12 week post-intervention follow-up
|
Baseline and 12 week post-intervention follow-up
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
기간: Baseline and 12 week post-intervention follow-up
|
Baseline and 12 week post-intervention follow-up
|
Evaluate program feasibility (telephone call completion rates)
기간: 12 week post-intervention follow-up
|
12 week post-intervention follow-up
|
Patient satisfaction (satisfaction questionnaire)
기간: 12 week Post-intervention follow-up
|
12 week Post-intervention follow-up
|
Patient qualitative feedback (qualitative questionnaire)
기간: 12 week Post-intervention follow-up
|
12 week Post-intervention follow-up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: John D Piette, PhD, University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .