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Healthy Parent Carers Feasibility Study

2020년 9월 11일 업데이트: University of Exeter

Healthy Parent Carers Programme: Feasibility Study of a Peer-led Group-based Health Promotion Intervention for Parent Carers of Disabled Children Using a Parallel Group Randomised Controlled Trial Design

This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The objectives of the study are:

  1. to evaluate whether the programme can be delivered in the community, and
  2. to provide information necessary to design a definitive randomised controlled trial.

The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).

The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.

Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.

Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.

연구 유형

중재적

등록 (실제)

93

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 영국
    • Cornwall
      • Saint Austell, Cornwall, 영국, PL26 6AZ
        • Children's Hospice South West Little Harbour
    • Devon
      • Bideford, Devon, 영국, EX39 2EY
        • Learn Devon Bideford
      • Dawlish, Devon, 영국, EX7 9SF
        • Orchard Manor School
      • Plymouth, Devon, 영국, PL6 5ES
        • Woodlands School
      • Torquay, Devon, 영국, TQ2 5QB
        • Torbay Parent Carer Forum
    • Somerset
      • Minehead, Somerset, 영국, TA24 5AP
        • The Beach Hotel

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

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs & Disability (SEND) legislation and The Children's Act);

    b) Willing and able to attend the programme group meeting session(s) on arranged dates/times;

    c) Able to access online information.

Exclusion Criteria:

  • a) Not able to communicate in English.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Group programme
Healthy Parent Carers group programme: A group-based peer led manualised programme called Healthy Parent Carers. The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions.
행동: Healthy Parent Carers group programme
Peer-led group-based weekly programme.
활성 비교기: Online resources
Healthy Parent Carers online resources: Online resources from the Healthy Parent Carers programme, including materials for 12 modules and related videos and audio files to illustrate the content.
행동: Healthy Parent Carers online resources
Online resources related to health and wellbeing

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Warwick-Edinburgh Mental Well-being Scale
기간: 6 months post-intervention
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
6 months post-intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Warwick-Edinburgh Mental Well-being Scale
기간: Baseline
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
Baseline
Warwick-Edinburgh Mental Well-being Scale
기간: Immediately post-intervention (up to 12 weeks)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
기간: Baseline
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Baseline
EQ-5D-5L
기간: Immediately post-intervention (up to 12 weeks)
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
기간: 6 months post-intervention
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
6 months post-intervention
PHQ-9
기간: Baseline
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Baseline
PHQ-9
기간: Immediately post-intervention (up to 12 weeks)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Immediately post-intervention (up to 12 weeks)
PHQ-9
기간: 6 months post-intervention
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
6 months post-intervention
Health Promoting Activities Scale
기간: Baseline
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Baseline
Health Promoting Activities Scale
기간: Immediately post-intervention (up to 12 weeks)
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Immediately post-intervention (up to 12 weeks)
Health Promoting Activities Scale
기간: 6 months post-intervention
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
6 months post-intervention
Patient Activation Measure (PAM)
기간: Baseline
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Baseline
Patient Activation Measure (PAM)
기간: Immediately post-intervention (up to 12 weeks)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Immediately post-intervention (up to 12 weeks)
Patient Activation Measure (PAM)
기간: 6 months post-intervention
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
6 months post-intervention
Parents' Assessment of Protective Factors
기간: Baseline
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Baseline
Parents' Assessment of Protective Factors
기간: Immediately post-intervention (up to 12 weeks)
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Immediately post-intervention (up to 12 weeks)
Parents' Assessment of Protective Factors
기간: 6 months post-intervention
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
6 months post-intervention
ICEpop CAPability measure for Adults (ICECAP-A)
기간: Baseline
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Baseline
ICEpop CAPability measure for Adults (ICECAP-A)
기간: Immediately post-intervention (up to 12 weeks)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Immediately post-intervention (up to 12 weeks)
ICEpop CAPability measure for Adults (ICECAP-A)
기간: 6 months post-intervention
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
6 months post-intervention
Service and Resource Use questionnaire
기간: Baseline
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Baseline
Service and Resource Use questionnaire
기간: Immediately post-intervention (up to 12 weeks)
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Immediately post-intervention (up to 12 weeks)
Service and Resource Use questionnaire
기간: 6 months post-intervention
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
6 months post-intervention
Programme Feedback Form
기간: Immediately post-intervention (up to 12 weeks)
We will collect feedback from treatment and control arm participants about the Healthy Parent Carer materials and delivery via a feedback form. All participants will be asked to complete the feedback form at 15 weeks post-randomisation.
Immediately post-intervention (up to 12 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Exeter

협력자

University of Oxford

수사관

  • 수석 연구원: Chris Morris, DPhil, University of Exeter

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

유용한 링크

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)

2018년 10월 29일

기본 완료 (실제)

2020년 2월 4일

연구 완료 (실제)

2020년 2월 4일

연구 등록 날짜

최초 제출

2018년 10월 10일

QC 기준을 충족하는 최초 제출

2018년 10월 10일

처음 게시됨 (실제)

2018년 10월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 9월 11일

마지막으로 확인됨

2020년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • NIHR RfPB PB-PG-0317-20044
  • 246169 (기타 식별자: IRAS)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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