Condition category
Respiratory
Date applied
22/10/2020
Date assigned
17/12/2020
Last edited
17/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
End of life care (palliative care ) is support for people who are in the last months or years of their life.
One of the reasons why palliative care does not completely fulfil population needs is that most of the palliative care programmes and units are more focused and addressed to patients with cancer.
The aim of the project and the clinical trial is to find out whether early intervention of palliative care services for non-cancer patients (respiratory (COPD / multi-morbid)) can help improve their quality of life during the later stages of their disease.

Who can participate?
Patients over the age of 65 with respiratory disease and a small number of their carers/health care professionals can take part if they meet the inclusion and exclusion criteria.

What does the study involve?
The study involves two stages. Stage one is a randomised controlled trial of Care as Usual versus an intervention of a Palliative Care Needs Assessment (400 participants across the 5 sites). Stage 2 is five different site based pilot interventions or care as usual. These interventions are largely focused on remote delivery of supportive/quality of life interventions.

What are the possible benefits and risks of participating?
Possible benefits of taking part are (if engaging with the interventions) receiving improved focus on patient needs, and if in Stage 2 being offered online support.

Where is the study run from?
1. NHS Highland (UK)
2. University of Leeds (UK)
3. Santa Casa Da Misericordia Da Amadora (Portugal)
4. Aristotle University of Thessaloniki (Greece)
5. Hospital Universitario y Politécnico La Fe (Spain)

When is the study starting and how long is it expected to run for?
June 2019 to November 2022.

Who is funding the study?
European Union Horizon 2020 Programme.

Who is the main contact?
Frances Hines, frances.hines@nhs.scot

Trial website

http://www.inadvanceproject.eu/

Contact information

Type

Public

Primary contact

Ms Frances Hines

ORCID ID

Contact details

NHS Highland RDI Division Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)1463255822
frances.hines@nhs.scot

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 270472

Study information

Scientific title

Clinical trial of outcomes from early interventions for palliative care patients - a stratified approach for severe respiratory illness and multimorbidities using a pilot randomised controlled trial (InAdvance)

Acronym

InAdvance

Study hypothesis

Are clinical and quality of life benefits obtainable from early interventions of palliative care for patients with severe respiratory disease and/or multimorbidities from the perspective of patients, carers and health care professionals?

Ethics approval

Approval pending, ref: 20/SC/0415

Study design

Multicentre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Later stage respiratory disease (COPD/multimorbidity) patients (and their carers and healthcare professionals (HCP)

Intervention

The Stage One intervention is a Needs Assessment; this will take place at one visit, either face-to-face or remotely, by trained personnel, with follow-up of 12 months

The Stage Two interventions vary per site and will start after 12 month assessments –
• NHSH and Leeds will randomise to usual care or a Remotely Delivered Living Well Course - hour-long weekly sessions lasting 8 weeks using video-conferencing techniques.
• Hospital Universitari i Politècnic la Fe, Valencia, Spain will randomise to usual care or a Multi-dimensional 9 Step Programme of intervention activities including physical therapy, psychological support and caregiver support – duration 6 months
• Santa Casa da Misericórdia da Amadora, Portugal will randomise to Care as Usual or to a Multi-Stage Programme of Palliative Care including early referral to national Palliative Care network, multi-disciplinary support team, Health Promotion Programme, Carers support and Loss & Grief support – duration 6 months.
• Hippokrateio General Hospital of Thessaloniki, Greece, will use randomise to usual care or an electronic platform containing patient-centred tools for self-support combined with e-forums for peer support along with live empathy sessions for care professionals, as well as using a monitoring system for pressure ulcers, and an AI-based behavioural intervention to improve self-management - duration 6 months.

The randomisation process is a sequential, two stage, unstratified 50/50 process - first to Standard care vs Needs Assessment (Stage one Intervention), then to standard care vs Stage two intervention by means of the CASTOR web-based randomisation allocation system

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Stage One
Measured at baseline, 6 weeks, 6 months, 12 months and 18 months
1. Quality of life (EQ-5D-5L)
2. Intensity of symptoms (POS1/POS2)
3. Functional status (PPSv2)

Stage 2
Measured at baseline, 6 weeks, 6 months, 12 months and 18 months
1. Quality of life (EQ-5D-5L)
2. Intensity of symptoms (POS1/POS2)
3. Functional status (PPSv2)

Secondary outcome measures

Measured at baseline, 6 weeks, 6 months, 12 months and 18 months (unless otherwise noted):
1. Emotional distress (HADS)
2. Within-trial cost analysis of participants’ service use and out of pocket expenses measured using patient interview
3. For carers: caregiving burden (brief ZBI)
4. Perceived quality of care is assessed among patients and carers using a 5-point Likert scale
5. Treatment adherence measured using the Treatment Acceptability/Adherence Scale and the Medical Outcomes Study tool
6. Treatment adherence, acceptability, appropriateness and feasibilty will assessed by qualitative interview with staff using data collection tools based on the Consolidated Framework for Implementation Research (CFIR) at baseline and 18 months
7. Cost categories measured for cost-consequence analysis and cost-effectiveness to be calculated at 18 months:
7.1. The intervention costs: Resource units consumed and their unit costs will be collected using uniform reporting templates. Depending on the intervention, resource units may concern the minutes spent by health and social care professionals (e.g. medical specialists, nurses, social workers, other therapists), diagnostic procedures (e.g. medical imaging, laboratory services), consumables (e.g. drugs, fluids and disposables) and overheads.
7.2. Other healthcare costs will be measured with the Medical Consumption Questionnaire (MCQ), which will be completed by patients. The MCQ includes questions related to frequently occurring contacts with health care providers.
7.3. Informal care costs will be determined by multiplying the number of hours taking care of the patient with corresponding hourly productivity costs. The number of hours taking care of the patient will be collected using items from the Valuation of Informal Care Questionnaire (VICQ).

Overall trial start date

01/06/2019

Overall trial end date

30/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patient:
1. Severe respiratory illness related to COPD or has respiratory disease as part of multimorbid state
2. Over the age of 55
3. Identified using the stratification model as being appropriate for receiving support / palliative care
4. Able to give written informed consent
5. Carer/HCP related to the patient participating also included as long as able to give written informed consent/adult

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Stage 1 400 across 5 sites / Stage 2 200 across 5 sites

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2021

Recruitment end date

30/10/2022

Locations

Countries of recruitment

Greece, Portugal, Spain, United Kingdom

Trial participating centre

NHS Highland RDI Division Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom

Trial participating centre

University of Leeds
Academic Unit of Palliative Care School of Medicine Worsley Building
Leeds
LS2 9JT
United Kingdom

Trial participating centre

Hospital Universitario y Politécnico La Fe
Avinguda de Fernando Abril Martorell, 106
València
46026
Spain

Trial participating centre

Aristotle University of Thessaloniki
School of Medicine University Campus
Thessaloniki
54124
Greece

Trial participating centre

Santa Casa Da Misericordia Da Amadora
Estrada da Portela
Quinta das Torres
2610-143
Portugal

Sponsor information

Organisation

NHS Highland

Sponsor details

NHS Highland RDI Division Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)1463 255822
nhsh.randd@nhs.scot

Sponsor type

Hospital/treatment centre

Website

https://www.nhshighland.scot.nhs.uk/Pages/welcome.aspx

Funders

Funder type

Government

Funder name

Horizon 2020 Framework Programme

Alternative name(s)

EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, H2020

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

As part of a large scale EU funded project with a total of 14 organisations as partners, it is expected there will be a large number of academic and clinical publications in a wide range of peer reviewed journals. Contributions to conferences and other events has already taken place and will continue to occur.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
The final goal is to make data openly accessible for as long as possible and for as long as the information they contain are relevant for further research purposes. The decision about the long-term provision of data collected and processed under the InAdvance project will be taken as the data are stored. After completing the trials, data collected during the InAdvance project will be openly accessible if the following requirements are met: i) data collection and processing are completed.; ii) data checking – in terms of quality control – is performed; and iii) after the completion of consortium partners' exploitation plan both in terms of scientific publications and commercial purposes. A possible period to make InAdvance data openly accessible may be 2 years after data collection. However, this time frame will be discussed and agreed by the project General Assembly. Also, discussions about licenses and terms of re-use will be also done by the project General Assembly, with the support and/or supervision of the Data Protection Officer and the Ethics Advisory Board, if necessary.

Intention to publish date

30/11/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: Trial’s existence confirmed by Oxford B REC.