Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05705154 |
| Other study ID # |
315063 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2023 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Royal Brompton & Harefield NHS Foundation Trust |
| Contact |
Samatha Sonnappa, MD PhD |
| Phone |
02073528121 |
| Email |
s.sonnappa[@]rbht.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recruitment target: Phase I: Co-design of intervention: 5 to 15 CYP aged between 12-18 years
of age referred to the pan-London long COVID MDT.
Phase II: Randomised pilot: 40 patients (12-18 years) will be recruited from a potential pool
of 214 patients referred to the pan-London long COVID MDT.
Methods: Phase I: Co-design Design and setting The intervention will be co-designed with CYP
following a process informed by practice-base evidence, which centres the voices and wisdom
of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The
process will involve: 1) Refining the intentions of key stakeholders (including ways of
bringing psychological and physiological principles into the intervention); 2) Participation
of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022).
Phase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool
of 214 patients referred to the pan-London long COVID MDT. CYP will be randomised to receive
either standard treatment or standard treatment plus intervention.
Study Treatment Standard treatment consists of virtual MDT discussion with referrer and
advice signposting into local services for specific issues. They are sent leaflets and
information. If a patient is severely affected enough to be seen face to face, they are
offered an interdisciplinary consultation, and tailored input from therapies and
psychological services.
Access to bite size videos and leaflets covering the following topics: sleep, pacing,
activity management, school reintegration, managing friendships, eating well and emotional
wellbeing. Young people are invited to a single virtual group Q&A session to bring any
queries after watching the videos.
The leaflets and online sessions have been developed by professionals from the Evelina, Great
Ormond Street Hospital, Imperial, University College London Hospital, and the Whittington.
The bite size videos and live sessions are delivered by a clinical psychologist, a dietitian,
specialist nurse, occupational therapist, and physiotherapist. More complex or severely
affected patients will receive one to one treatment with members of the MDT as required.
Intervention
Based on clinical expertise and theory, it is anticipated the following elements may be
included in the intervention.:
- Progressive breathing pattern retraining, including education, self-observation,
relaxation, body scanning, postural re-alignment
- Identifying the connections between body and mind to address anxiety and breathlessness
- Coping skills for managing anxiety using principles from narrative therapy and
mindfulness
- Online materials to improve self-efficacy with home practice
- Social connection with other CYP for peer support, and resource sharing
- Activities to help CYP reconnect with their usual activities, skills, abilities,
interests, support systems
Description:
Hypotheses: CYP with a diagnosis of Long COVID who complete the intervention in addition to
standard treatment will show a greater improvement in psychological wellbeing and demonstrate
fewer functional limitations of excessive breathlessness after completing a holistic modular
psychological and respiratory physiotherapy (PT) intervention compared to current standard
treatment alone.
Primary objective Impact score of Strength and Difficulties (SDQ) questionnaire (included in
ISARIC form - standard care assessment).
-RCADS questionnaire (17), pre- and post-intervention.
Secondary Objectives
To further answer the Ho the following measures will be taken:
- Improved dysfunctional breathing measured by multi-dimensional physiotherapy assessment
of breathing pattern including Nijmegen questionnaire, breathing pattern category, SMART
goal setting, lung function and cardiopulmonary exercise testing and specialist
physiotherapist assessment of breathing pattern quality pre- and post-intervention.
- At baseline and 6-monthly, all CYP will complete the standard assessment questionnaires
for the long COVID pan-London pathway in line with the NHSE commissioning guidance which
includes the following questionnaires to assess quality of life, psychological
well-being, and adaptive functioning.
- Revised Children's Anxiety and Depression Scale (RCADS) questionnaire (17), pre-
and post-intervention.
- EQ-5D-Y (25)
- SF-36 Quality of life (26)
- 11-item Chalder Fatigue Questionnaire (27) and
- Visual analogue pain scale
- FitBit Activity monitoring including daily step counts, daily distance travelled,
daily stairs climbed, sedentary minutes, low, moderate and vigorous activity
minutes, sleep hours, and wear time.
Secondary research question: Are co-designed virtual psychology and physiotherapy
interventions acceptable and feasible to service users?
Quantitative data: participation, attendance and dropout rates will be collected. Technical
issues with being able to access the intervention will be documented.
Qualitative feedback will be obtained to enable development of the intervention.
-The facilitators will gather live feedback towards the end of each group session using a
range of approaches. As part of the focus groups the CYP will review the outcome measure to
get feedback if these are the things that matter to them the most. Activities to explore
outcomes that matter to CYP will be reviewed in the focus groups.
Qualitative feedback will also be obtained after completion of all the group sessions when
the investigator administers the post-intervention measures. This will include measures of
usefulness, willingness to recommend to a friend, and qualitative questions on experience of
the group, best parts of the group, and suggestions for improvement.
The investigator will also assess the impact of prior mental health problems, severity of
COVID infection (community acquired vs. hospitalised) and prior functioning on intervention
response.
Study Design The project is a Pan-London research project recruiting patients from across
London.
The objectives of this two-part research project are firstly to co-design a novel holistic
group intervention with children and young people with long COVID. The intervention will be
developed based on existing literature and interventions for psychological distress and for
dysfunctional breathing in similar clinical cohorts, and from focus groups with CYP with long
COVID and their parents/ caregivers to ensure acceptability and appropriateness.
The second phase of this project will be to prospectively pilot the new services to assess
the efficacy, acceptability, and feasibility from both the service user and service
providers. The intervention will be piloted in a cohort of CYP with long COVID as an
adjunctive intervention to treatment as usual, assessing impact on well being and breathing
outcomes.
Phase I. Co-design Method Design and setting The intervention will be co-designed with CYP
following a process informed by practice-base evidence, which centres the voices and wisdom
of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The
process will involve: 1) Refining the intentions of key stakeholders (including ways of
bringing psychological and physiological principles into the intervention); 2) Participation
of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022).
Participation of CYP will include:
- The use of group interventions co-designed with CYP with other conditions such as
diabetes, chronic pain, myalgic encephalomyelitis/chronic fatigue syndrome and medically
unexplained conditions as examples to help CYP with long COVID consider some
possibilities and enable them to develop their own ideas for the intervention.
- Responding to feedback and recruitment of CYP 'advisors' (name and responsibilities
included in the role to be agreed with CYP)
- The use of focus groups guided by 4Pi framework and principles (NSUN, 2015) including
openness and transparency about the process, finding ways to ensure the meaningful
involvement of all CYP with long COVID, including those from black and minority ethnic
communities, LGBTQ+ young people and other 'marginalised' groups to co-design and
develop the intervention, consider recruitment and outcome measures.
The University College London Hospitals (UCLH) psychology team have developed a number of
innovative and award-winning groups (20-24) that will be used as exemplars to help young
people think what they might want to be included in the groups as well as delivery style
(e.g., vlogs and podcasts versus leaflet), preferred frequency and length. Parents will also
be invited to attend a focus group and invited to comment on similar questions. The
investigators are planning to offer the groups for the CYP unaccompanied by parents.
- As part of the focus groups the CYP will review the outcome measures to get feedback if
these are the things that matter to them the most. Activities to explore outcomes that matter
to CYP will be reviewed in the focus groups.
Each focus group session will be via zoom and be recorded. The recording will be downloaded
to a secure encrypted hospital drive. The audio recording will be used to transcribe into a
script. Once this script is checked the video and audio recordings can be deleted.
Co-design participants Service Users: The investigators aim to recruit 5 to 15 young people
Inclusion: CYP aged between 12-18 years old who have been referred into the Pan-London Long
COVID Multi-disciplinary Team (MDT) Clinic from its inception in 2020.
Exclusion: No objective evidence of SARS-CoV-2 infection e.g., positive PCR testing or
antibodies. Significant neurodevelopmental difficulties (severe autism spectrum disorder
(ASD), attention deficit hyperactivity disorder (ADHD), global intellectual disability)
and/or high psychiatric risk e.g., suicidality, severe emotional or behavioural dysregulation
precluding participation in group intervention (PI screened during the MDT discussion and by
lead researcher during telephone call for recruitment).
Phase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool
of 214 patients referred to the pan-London long COVID MDT.
Inclusion criteria: All patients aged 12-18 years referred to the pan-London long COVID MDT
with English of a standard adequate to participate in a group intervention.
Exclusion criteria: No objective evidence of SARS-CoV-2 infection e.g., positive PCR testing
or antibodies. Significant neurodevelopmental difficulties (severe autism spectrum disorder
(ASD), attention deficit hyperactivity disorder (ADHD), global intellectual disability)
and/or high psychiatric risk e.g., suicidality, severe emotional or behavioral dysregulation
precluding participation in group intervention (PI screened during the MDT discussion and by
lead researcher during telephone call for recruitment).
Process: Informed consent or assent will be obtained from all CYP, and parental consent
obtained for CYP under 16 years. Parents will be given access to all resources, although the
intervention will be targeted towards the CYP.
Each CYP will complete a screening assessment for suitability for the trial. Once a potential
participant has consented to take part they will have a Cardio-Pulmonary Exercise Test (CPET)
test, lung function, 1:1 breathing pattern assessment by a respiratory physiotherapist and
set up with a FitBit monitor before randomisation.
Each Fitbit will be set up by the lead researcher to a new outlook account linked to the
participant number. The research team will be able to download data on daily step counts,
daily distance travelled, daily stairs climbed, sedentary minutes, low, moderate and vigorous
activity minutes, sleep hours, and wear time. The Fitbit will be synced to the patient's
mobile phone in clinic so they can review their daily data as well. The Fitbit account will
be set up with a generic date of birth, weight, and height so not to identify the patient.
CYP will be randomised (using a block randomisation approach) to receive either standard
treatment or standard treatment plus intervention.
Standard treatment consists of virtual MDT discussion with referrer and advice signposting
into local services for specific issues. They are sent leaflets and info on online videos
(webinars) and directed to standardised information on the Your COVID Recovery Website If a
patient is severely affected enough to be seen face to face, they are offered an
interdisciplinary consultation, and tailored input from PT, occupational therapy (OT) and
psychological services.
Access to bite size videos and leaflets and other standardised information covering the
following topics: sleep, pacing, activity management, school reintegration, managing
friendships, eating well and emotional wellbeing. Young people are invited to a single
virtual group Q&A session to bring any queries after watching the videos/ webinars.
The leaflets have and online sessions have been developed by professionals from the Evelina,
Great Ormond Street Hospital, Imperial, University College London Hospital, and the
Whittington. Additional information is being developed in online video/ webinar form as the
services evolve. The bite size videos/ webinars and live sessions are delivered by a clinical
psychologist, a dietician, specialist nurse, occupational therapist and physiotherapist. More
complex or severely affected patients will receive one to one treatment with members of the
MDT as required.
Intervention
Based on clinical expertise and theory, it is anticipated the following elements may be
included in the intervention:
- Progressive breathing pattern retraining, including education, self-observation,
relaxation, body scanning, postural re-alignment
- Identifying the connections between body and mind to address anxiety and breathlessness
- Coping skills for managing anxiety using principles from narrative therapy and
mindfulness
- Online materials to improve self-efficacy with home practice
- Social connection with other CYP for peer support, and resource sharing
- Activities to help CYP reconnect with their usual activities, skills, abilities,
interests, support systems.
