Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
2020년 11월 30일 업데이트: University of Kansas Medical Center
Teen Connections for Support From Multidisciplinary Professionals & Peers
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
연구 개요
상태
완전한
상세 설명
This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers.
Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups.
Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers.
Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.
연구 유형
중재적
등록 (실제)
83
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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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
13년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older
- TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder
- Read, write, speak English and provide informed consent
- Be able to participate in group clinic visits
Exclusion Criteria:
- Enteral nutrition dependency only
- Less than 13 years of age
- 13 through 17 years of age without parental consent
- Currently enrolled in an intervention study or HPN management program
- Severe cognitive impairment
- Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Group One
Intervention
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mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.
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활성 비교기: Group Two
Control
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iPad with a data plan and one professionally moderated iPad visual meeting with peers.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health Survey SF-12v2 (predicts future health services use).
기간: T0 (baseline data collection)
|
Physical and mental health status from each person's perspective.
7-Item Likert
|
T0 (baseline data collection)
|
|
Quality of Life (Cantril Ladder)
기간: T0 (baseline data collection)
|
Ratings of quality of life over time that are sensitive to changes in health.
3-Item Likert
|
T0 (baseline data collection)
|
|
Beck Depression Inventory-II (BDI-II)
기간: T0 (baseline data collection)
|
Assesses assess the intensity of depression into alignment with DSM-IV criteria.
Each item is a list of four statements arranged in increasing severity about a particular symptom of depression.
21-Item
|
T0 (baseline data collection)
|
|
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
기간: T2 (month 1-2/mConnect intervention period)
|
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
|
T2 (month 1-2/mConnect intervention period)
|
|
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
기간: T3 (month 3-4/mConnect intervention period)
|
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
|
T3 (month 3-4/mConnect intervention period)
|
|
Beck Depression Inventory-II (BDI-II)
기간: T3 (4 months: change from T0/baseline)
|
Assesses assess the intensity of depression into alignment with DSM-IV criteria.
Each item is a list of four statements arranged in increasing severity about a particular symptom of depression.
21-Item
|
T3 (4 months: change from T0/baseline)
|
|
Health Survey SF-12v2 (predicts future health services use).
기간: T3 (4 months: change from T0/baseline)
|
Physical and mental health status from each person's perspective.
7-Item Likert
|
T3 (4 months: change from T0/baseline)
|
|
Quality of Life (Cantril Ladder)
기간: T3 (4 months: change from T0/baseline)
|
Ratings of quality of life over time that are sensitive to changes in health.
3-Item Likert
|
T3 (4 months: change from T0/baseline)
|
|
Health Survey SF-12v2 (predicts future health services use).
기간: T4 (8 months: change from T3/4 months)
|
Physical and mental health status from each person's perspective.
7-Item Likert
|
T4 (8 months: change from T3/4 months)
|
|
Quality of Life (Cantril Ladder)
기간: T4 (8 months: change from T3/4 months)
|
Ratings of quality of life over time that are sensitive to changes in health.
3-Item Likert
|
T4 (8 months: change from T3/4 months)
|
|
Beck Depression Inventory-II (BDI-II)
기간: T4 (8 months: change from T3/4 months)
|
Assesses assess the intensity of depression into alignment with DSM-IV criteria.
Each item is a list of four statements arranged in increasing severity about a particular symptom of depression.
21-Item
|
T4 (8 months: change from T3/4 months)
|
|
Health Survey SF-12v2 (predicts future health services use).
기간: T5 (12 months: change from T4/8 months)
|
Physical and mental health status from each person's perspective.
7-Item Likert
|
T5 (12 months: change from T4/8 months)
|
|
Quality of Life (Cantril Ladder)
기간: T5 (12 months: change from T4/8 months)
|
Ratings of quality of life over time that are sensitive to changes in health.
3-Item Likert
|
T5 (12 months: change from T4/8 months)
|
|
Beck Depression Inventory-II (BDI-II)
기간: T5 (12 months: change from T4/8 months)
|
Assesses assess the intensity of depression into alignment with DSM-IV criteria.
Each item is a list of four statements arranged in increasing severity about a particular symptom of depression.
21-Item
|
T5 (12 months: change from T4/8 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Preparedness (measures skills needed for independent HPN home care).
기간: T0 (baseline data collection)
|
Ability to manage home-care; low score = needs home care assistance.
8-Item Likert
|
T0 (baseline data collection)
|
|
COOPS Social Support Scale
기간: T0 (baseline data collection)
|
Ratings on having others who help, listen & provide tangible assistance support.
13-Item Likert
|
T0 (baseline data collection)
|
|
Preparedness (measures skills needed for independent HPN home care).
기간: T3 (4 months: change from T0/baseline)
|
Ability to manage home-care; low score = needs home care assistance.
8-Item Likert
|
T3 (4 months: change from T0/baseline)
|
|
COOPS Social Support Scale
기간: T3 (4 months: change from T0/baseline)
|
Ratings on having others who help, listen & provide tangible assistance support.
13-Item Likert
|
T3 (4 months: change from T0/baseline)
|
|
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
기간: T4 (8 months)
|
Rating of Helpfulness and willingness to pay for mobile care delivery.
10-Item Likert
|
T4 (8 months)
|
|
Preparedness (measures skills needed for independent HPN home care).
기간: T4 (8 months: change from T3/4 months)
|
Ability to manage home-care; low score = needs home care assistance.
8-Item Likert
|
T4 (8 months: change from T3/4 months)
|
|
COOPS Social Support Scale
기간: T4 (8 months: change from T3/4 months)
|
Ratings on having others who help, listen & provide tangible assistance support.
13-Item Likert
|
T4 (8 months: change from T3/4 months)
|
|
Preparedness (measures skills needed for independent HPN home care).
기간: T5 (12 months: change from T4/8 months)
|
Ability to manage home-care; low score = needs home care assistance.
8-Item Likert
|
T5 (12 months: change from T4/8 months)
|
|
COOPS Social Support Scale
기간: T5 (12 months: change from T4/8 months)
|
Ratings on having others who help, listen & provide tangible assistance support.
13-Item Likert
|
T5 (12 months: change from T4/8 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Carol E Smith, RN, PhD, FAAN, University of Kansas Medical Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
2016년 7월 1일
기본 완료 (실제)
2019년 12월 1일
연구 완료 (실제)
2020년 6월 1일
연구 등록 날짜
최초 제출
2016년 12월 6일
QC 기준을 충족하는 최초 제출
2016년 12월 8일
처음 게시됨 (추정)
2016년 12월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 30일
마지막으로 확인됨
2020년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00004067
- R01NR015743-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
All data is de-identified and will be reported only in aggregate.
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. .