Singing for People With Aphasia (SPA)
2018년 10월 10일 업데이트: University of Exeter
Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
To undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical and cost effectiveness of SPA for people with aphasia)
연구 개요
상세 설명
Beyond language function, people with aphasia (PWA) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. These psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. National clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. This research is about singing groups for people with aphasia (SPA) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke.
The Investigators engagement activities and early development project provided strong impetus for the proposed study: people with aphasia repeatedly told the investigators that singing in groups may help the participants to reconnect with society, and that this will improve wellbeing.
The investigators have planned a pilot study that will allow an assessment of the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. The information from this work will help the investigators to decide whether to conduct a larger randomised controlled trial (RCT) which would be a fair test of whether SPA can improve the lives of individuals with post stroke aphasia.
연구 유형
중재적
등록 (실제)
41
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Exeter, 영국, EX1 2LU
- University of Exeter
-
-
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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of aphasia after stroke
- Willingness to be randomised to either control or SPA (and able to attend the singing venue)
- Conversational English speaker pre-morbidly
- Capacity to consent (assessed by recruiting team using standard tools)
Exclusion Criteria:
- <18 years old
- Currently engaged in a speech or language therapy programme
- Intention to relocate outside the geographical region during the study
- Current participation in another study involving a lifestyle intervention
- Currently attending a singing/music group
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Resource pack
Aphasia resource pack
|
Resource pack with information on living with aphasia and local community activities.
|
|
실험적: Singing group + resource pack
Singing group + Aphasia resource pack
|
SPA is a community-based, 10 weekly singing group.
Each SPA session comprises 30 minutes of settling in/wrap-up and departure, and 60 minutes of group singing.
Sessions will be led by a community music leader, co-facilitated by a person with aphasia, and involve the group singing from a songbook.
Musical accompaniment will be provided by the facilitator(s).
Small percussion instruments will be available for participants, enabling involvement of those with limited singing ability.
Intervention content integrates the Information-Motivation-Behavioural (IMB) skills model of health behaviour change to support individuals in developing the social skills and confidence needed to improve psychosocial outcomes.
Participants will also receive the resource pack.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ICEpop CAPability measure for Adults (ICECAP-A)
기간: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
A 5-item measure of capability for the general adult (18+) population for use in economic evaluation.
It focuses on wellbeing and comprises five attributes: Attachment, Stability, Achievement, Enjoyment, Autonomy.
|
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
|
Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
기간: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
A 39-item health-related quality of life measure with 4 subdomains: physical, psychosocial, communication, and energy.
|
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
|
EQ-5D-5L (health-related quality of life states consisting of five dimensions)
기간: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
A 5-item measure of health-related quality of life (plus EQ-VAS visual analogue scale), that can be used for cost utility analysis.
|
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
|
modified Reintegration to Normal Living (mRNL)
기간: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
An 11-item measure that captures social participation (e.g.
recreation, movement in the community, and interaction in family or other relationships).
|
Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Communication Outcome After STroke (COAST)
기간: Measures change from baseline to 6 months post intervention
|
A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
|
Measures change from baseline to 6 months post intervention
|
|
Very Short Version of the Minnesota Aphasia test
기간: Measures change from baseline to 6 months post intervention
|
A diagnostic tool to identify aphasia type.
Comprised of 4 activities: Identifying names, oral reading words, naming pictures, and written spelling.
Audio-recorded to allow for diagnosis of aphasia severity.
|
Measures change from baseline to 6 months post intervention
|
|
Service Receipt Inventory
기간: Measures change from baseline to 6 months post intervention
|
Record of types and amount of use of health and social care resources including clinical contacts, formal and informal social care.
Completed by Assessor drawing on participant and family accounts.
|
Measures change from baseline to 6 months post intervention
|
|
Care related Quality of Life (CarerQoL-7D)48
기간: Measures change from baseline to 6 months post intervention
|
For completion by carers.
A 7-item measures of the impact of providing informal care on carers.
Utility tariffs to calculate a weighted sum score of the CarerQol-7D are also available.
|
Measures change from baseline to 6 months post intervention
|
|
Adverse incidents
기간: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
|
Adverse events used to gauge the safety of the intervention
|
Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recruitment
기간: From the start of participant identification through to participant randomisation, over a period of 8 months
|
An assessment of the recruitment to the trial
|
From the start of participant identification through to participant randomisation, over a period of 8 months
|
|
Retention
기간: From Randomisation through study completion, an average of 36 weeks
|
An assessment of the retention rates in the trial
|
From Randomisation through study completion, an average of 36 weeks
|
|
Qualitative Interviews
기간: Interviews to be conducted 3 months post-intervention
|
15 Qualitative interviews across the intervention and control groups to discuss individuals' experiences of the trial processes and the intervention.
Participants will report on the acceptability of trial and intervention activities
|
Interviews to be conducted 3 months post-intervention
|
|
Intervention fidelity (intervention group only): Singing group attendance
기간: During the intervention, up to 10 weeks
|
A register of attendance at the singing group
|
During the intervention, up to 10 weeks
|
|
Intervention fidelity (intervention group only): Session adherence
기간: During the intervention, up to 10 weeks
|
Group facilitators will record which aspects of the intervention manual have been followed during the group session
|
During the intervention, up to 10 weeks
|
|
Intervention fidelity (intervention group only): Observations
기간: During the intervention, up to 10 weeks
|
The research team will observe and record the extent to which the group facilitators are following the key elements of the intervention manual and the participants are adhering to facilitator instructions
|
During the intervention, up to 10 weeks
|
|
Intervention fidelity (intervention group only): Video recordings
기간: During the intervention, up to 10 weeks
|
The research team will video-record a selection of singing group sessions to assess facilitator and participant adherence
|
During the intervention, up to 10 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Tarrant M, Carter M, Dean SG, Taylor R, Warren FC, Spencer A, Adamson J, Landa P, Code C, Backhouse A, Lamont RA, Calitri R. Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility. BMJ Open. 2021 Jan 13;11(1):e040544. doi: 10.1136/bmjopen-2020-040544.
- Tarrant M, Carter M, Dean SG, Taylor RS, Warren FC, Spencer A, Adamson J, Landa P, Code C, Calitri R. Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being. BMJ Open. 2018 Sep 10;8(9):e025167. doi: 10.1136/bmjopen-2018-025167.
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 (실제)
2017년 6월 1일
기본 완료 (실제)
2018년 9월 27일
연구 완료 (실제)
2018년 9월 27일
연구 등록 날짜
최초 제출
2017년 2월 28일
QC 기준을 충족하는 최초 제출
2017년 3월 6일
처음 게시됨 (실제)
2017년 3월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 10월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 10월 10일
마지막으로 확인됨
2018년 10월 1일
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. .