Evidence map›Paper›PMID 39414300›Full record

ArticleBMJ open2024

A Self-led Self-management Intervention Supporting Teens with IBD (ASSIST-IBD): protocol for a feasibility study of a novel digital treatment adherence intervention.

Cassandra Screti, Lou Atkinson, Rachel Shaw, Rafeeq Muhammed, Gemma Heath

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Cassandra ScretiInstitute of Health & Neurodevelopment, Aston University, Birmingham, UK.ORCID http://orcid.org/0000-0003-1233-0560
Lou AtkinsonAston University College of Health and Life Sciences, Birmingham, UK.
Rachel ShawInstitute of Health & Neurodevelopment, Aston University, Birmingham, UK.ORCID http://orcid.org/0000-0002-0438-7666
Rafeeq MuhammedBirmingham Women's and Children's Hospitals NHS Foundation Trust, Birmingham, UK.
Gemma HeathInstitute of Health & Neurodevelopment, Aston University, Birmingham, UK heathg1@aston.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTreatment non-adherence is common in young people with inflammatory bowel disease (IBD), yet support is lacking. A self-led self-management intervention supporting teens with IBD (ASSIST-IBD) is a new theory-based digital treatment adherence intervention, co-developed by young people living with IBD. ASSIST-IBD includes 10 short modules supporting adolescents to feel confident to follow their treatment plan, develop skills to overcome adherence obstacles, feel confident when talking to others about IBD and feel positive about the future. This research aims to determine the feasibility of implementing and measuring the effectiveness of ASSIST-IBD, using a single-arm mixed-methods feasibility trial. METHODS AND ANALYSIS: 24 young people (aged 13-17) with IBD identified as being ≤80% adherent, and their parents, will use ASSIST-IBD for 6-12 weeks. For the primary endpoint of progression to randomised controlled trial, qualitative and quantitative data will be collected on; number of eligible members of the target population; number of recruited participants; reasons for non-participation and ineligibility; retention and follow-up rates; reasons for early withdrawal; completeness and utility of outcome measures; as well as further data on intervention acceptability, user experiences and user engagement. Secondary outcomes of preliminary effectiveness will include pre-intervention and post-intervention measures of treatment adherence (MARS-5), quality-of-life (IMPACT-III) and well-being (WEMWBS), and self-reported behaviour change success. Quantitative data will be analysed using descriptive statistics; qualitative data will be analysed thematically. An active patient and public involvement and engagement group will advise on the research throughout, including the development of the protocol. ETHICS AND DISSEMINATION: The study has been granted ethical approval by Aston University's Health and Life Sciences Research Ethics Committee (ref:#HLS2112) and NHS Research Ethics Committee, Nottingham 1 Board (IRAS:#344918). Findings will be disseminated via peer-reviewed publications and lay summaries. REGISTRATION DETAILS: This protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/KC649).

Indexed as

Feasibility StudiesInflammatory Bowel DiseasesSelf-ManagementAdolescentFemaleHumansMaleTreatment Adherence and ComplianceAdolescentFeasibility StudiesInflammatory bowel diseaseMedication AdherencePaediatric gastroenterology

Identifiers

PMID39414300
PMCPMC11487816

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.