NCT03824210

Brief Summary

This study will co-produce and pilot-test a mobile phone App and a booklet, with input from local secondary schools and carer support groups to develop and pilot-test the App, in order to ensure it is designed to meet young people's needs. This App will serve to increase knowledge, information and provide strong links for young carers and local support available.This is a mixed methods study, using a transformative design. A transformative approach centres on users' needs and uses their experiences to shape how the App will look (in this case, uses are young carers). Carers will co-produce the App and booklet. The study will explore how a free app-based online support tool can help enhance support for young carers. Young carers have been involved since the outset and drove this planned study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

January 29, 2019

Last Update Submit

May 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • To understand young carer experiences, co-produce and develop an App for young carers 11yrs-18yrs age range in order to improve outcomes for family members and young carers

    Measured by qualitative feedback on the app via transcriptions. Includes understanding of transition points such as admission/discharge to hospital.

    18 months

Secondary Outcomes (4)

  • Formulation of a Young Carer Handbook

    18 months

  • Gain understanding of App usage

    18 months

  • Explore usefulness of the App and experience of caring over time

    18 months

  • Capture information on referral rates of Young Carers before and after App introduction

    18 months

Study Arms (2)

Stage 1

School children age 11-18 (from two nominated schools) and young carers 11-18

Other: App

Stage 2

Young carers from Young Carers in Herts 11-18

Other: App

Interventions

AppOTHER

Mobile phone app

Stage 1Stage 2

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young Carers in Hertfordshire

You may qualify if:

  • School children from nominated schools in Hertfordshire (stage 1)
  • Ability to provide informed consent (consent processes/literature will be age appropriate 11-17) (stage 2)
  • Able to complete questionnaires (stage 2)

You may not qualify if:

  • Does not speak or understand English
  • Lacks mental capacity
  • Young carers outside Hertfordshire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, SG14AB, United Kingdom

RECRUITING

MeSH Terms

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

March 20, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Identifiable data will not be shared with other researchers. The publication plan in the study protocol will be followed.

Locations