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Healthy Parent Carers Feasibility Study

11. září 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

93

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Healthy Parent Carers group programme
Peer-led group-based weekly programme.
Aktivní komparátor: 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.
Behaviorální: Healthy Parent Carers online resources
Online resources related to health and wellbeing

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Warwick-Edinburgh Mental Well-being Scale
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Warwick-Edinburgh Mental Well-being Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Exeter

Spolupracovníci

University of Oxford

Vyšetřovatelé

  • Vrchní vyšetřovatel: Chris Morris, DPhil, University of Exeter

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

29. října 2018

Primární dokončení (Aktuální)

4. února 2020

Dokončení studie (Aktuální)

4. února 2020

Termíny zápisu do studia

První předloženo

10. října 2018

První předloženo, které splnilo kritéria kontroly kvality

10. října 2018

První zveřejněno (Aktuální)

15. října 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. září 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. září 2020

Naposledy ověřeno

1. září 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • NIHR RfPB PB-PG-0317-20044
  • 246169 (Jiný identifikátor: IRAS)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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