A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition
Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
연구 개요
상세 설명
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.
Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21201
- Fayette Street Clinics
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Current documented chart diagnosis of at least one chronic medical condition
- Received clinic services for a minimum of 3 months prior to study entry
- English-speaking
- Willing to use an effective form of birth control throughout the study if sexually active
Exclusion Criteria:
- History of a serious neurological disorder or head trauma with loss of consciousness
- Diagnosed with mental retardation or dementia
- Diagnosed with end stage organ disease
- Currently receiving chemotherapy and/or radiation treatment for cancer
- Received psychiatric hospitalization less than 3 months prior to study entry date
- Blind and/or deaf
- Pregnant
- Infected with HIV with a CD4 count under 350
- Diagnosis of AIDS
- Diagnosis of anorexia
- Problematic substance use, as defined by a mental health provider
- Psychiatric instability, as defined by a mental health provider
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
Participants will receive a self-management program for chronic illness
|
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
|
|
간섭 없음: Usaual Care
Usual Care; no additional intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Health-related self-efficacy and recovery orientation
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical illness self-management skills
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Social and communication skills during interactions with health care providers
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Physical and mental health status
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Medical service use patterns
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Medication use
기간: Measured throughout the study
|
Measured throughout the study
|
|
Neurocognition
기간: Measured at baseline
|
Measured at baseline
|
|
Substance abuse
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Psychiatric symptoms
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Amount and seriousness of related comorbidities
기간: Measured at pre- and post-intervention
|
Measured at pre- and post-intervention
|
|
Quantitative and qualitative survey ratings
기간: Measured throughout the study
|
Measured throughout the study
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Richard W. Goldberg, PhD, University of Maryland, College Park
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HP-00040526
- DAHBR 96-BHB
- R34MH078168 (미국 NIH 보조금/계약)
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. .