Condition category
Nervous System Diseases
Date applied
19/03/2018
Date assigned
29/03/2018
Last edited
29/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson's disease is a condition in which parts of the brain become progressively damaged over many years. People with Parkinson's (PwP) report being diagnosed as devastating and could be better handled with a subsequent reduction in stress and anxiety for those affected and their families. Stress and anxiety have been highlighted as one of the top 10 research priorities for PwP with the need for improvement in the information those newly diagnosed receive. The aim of this study is to assess the First Step program for taking control after diagnosis, which has been developed by PwP for PwP.

Who can participate?
Patients aged over 18 with a diagnosis of Parkinson's within the previous 12 months

What does the study involve?
The First Step program consists of two workshops over a 6-week period. The workshops are delivered by PwP who provide information on how to face the future positively, address fears and misconceptions and how they can help manage the condition themselves. Participants are asked to complete assessments delivered over the phone, through the post or online before starting the program and after 3 and 6 months. Questions are asked about health, wellbeing and activity. People’s experiences of the program and the study are also collected.

What are the possible benefits and risks of participating?
There is minimal risk associated with assessment and the study has been designed to minimise burden on the participants. Assessment takes place over the phone at a time convenient to the participant, thus avoiding the need to travel. Follow-up assessment should take no longer than 40 minutes, with assessments at the start of the study taking longer due to the consenting procedure and obtaining demographic information. Whilst unlikely, the questionnaires used in the study may cause mild distress to participants. However, they are all commonly used in both research and clinical practice and the researcher will have adequate experience of their use.

Where is the study run from?
The program takes place in suitable community venues in Oxfordshire, Hampshire or Surrey (when the program becomes available). Currently the Oxfordshire program runs out of Witney Lakes Resort.

When is the study starting and how long is it expected to run for?
June 2017 to November 2018

Who is funding the study?
Parkinson's UK

Who is the main contact?
Sophie Lawrie

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sophie Lawrie

ORCID ID

Contact details

Oxford Brookes University
Headington Campus
Oxford
OX3 0BP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35346

Study information

Scientific title

The First Steps pathway for taking control after a diagnosis of Parkinson’s: a feasibility study

Acronym

Study hypothesis

People with Parkinson's (PwP) report being diagnosed as devastating and could be better handled with a subsequent reduction in stress and anxiety for those affected and their families. Stress and anxiety have been highlighted as one of the top 10 research priorities for PwP (James Lind Alliance) with the need for improvement in the Information those newly diagnosed receive. This research is to evaluate the ‘First Step program' for taking control after diagnosis, which has been developed by PwP for PwP.

Ethics approval

South Central - Hampshire A Research Ethics Committee, 23/08/2017, ref: 17/SC/0346

Study design

Non-randomised; Interventional; Design type: Treatment, Complex Intervention

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Parkinson's Disease; UKCRC code/ Disease: Neurological/ Extrapyramidal and movement disorders

Intervention

Adults with diagnoses of Parkinson's within the previous 12 months, will be invited to attend the program and be offered the opportunity to take part in the research. It will be made clear to individuals that taking part in the program is not dependent on them taking part in the research.

The program will take place in suitable community venues in Oxfordshire, Hampshire or Surrey (when the program becomes available). Currently the Oxfordshire program runs out of Witney Lakes Resort.

The First Step program consists of two workshops over a 6-week period. The workshops are delivered by pwp who provide information on how to face the future positively, address fears and misconceptions and how they can help manage the condition themselves. Those taking part in the research will be asked to take part in assessments delivered over the phone. The EPIC Questionnaire will be completed at their convenience either through post or by completing online. Assessment will take place before starting the program (baseline) and at 3 months and 6 months. At assessment we will asks questions about health, wellbeing and activity, using standard questionnaires. People’s experiences of the program and the research will also be asked. All people taking part in the research will have the opportunity to receive the program, however, delivery of the program will begin when available in that area.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Acceptability, assessed using Process Evaluation Questionnaire (view of venue, staff/facilitator, course content, ease of attendance, impact)
2. Demographics (age, gender, ethnicity, socioeconomic status and rural or urban home, employment)
3. Adherence: % of attendance for Day 1 and Day 2 of First Steps Program
4. Eligibility: number of people screened and that match the eligibility criteria
5. Recruitment: rate of eligible participants enrolled onto the study (%), rate of eligible patients that attended First Steps (%)
6. Retention: no. of enrolled patients that completed the 6 month telephone assessment, number of patients that completed the process evaluation questionnaire, number of patients that completed each outcome measure at baseline, 3 months and 6 months
7. Step-wedge trial: differences in onset of programme provision, number of patients who have attended and not attended First Steps per site
8. Fidelity of delivery, assessed using fidelity checklist at delivery of program

Secondary outcome measures

1. Generic health status is measured by the Euro-QOL (EQ5D-5L) questionnaire at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
2. Anxiety and depression is measured by the Hospital, Anxiety and Depression Scale (HaDs) at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
3. Social participation is measured by the World Health Organisation Disability Assessment Schedule (WHODAS) at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
4. Service use is measured by the modified Client Service Receipt Inventor (modified CSRI) at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
5. Activities of daily living is measured by the Schwab and England (S&E) questionnaire at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
6. Physical activity is measured by the International physical activity questionnaire-short version (IPAQs) at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
7. Diet over the past year is measured by the EPIC-Norfolk Food Frequency Questionnaire. At baseline (0 weeks) a link to an online version of the EPIC questionnaire OR a paper copy is sent by post to the participant to be completed at the participants convenience
8. Diet over the previous day is measured using the 24-hour Food Recall at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)
9. Carer strain is measured by the Caregiver Strain Index at baseline (0 weeks), three months (12 weeks) and six months (24 weeks)

Overall trial start date

01/06/2017

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. A recent (within 12 months) diagnosis of Parkinson’s disease
2. Above the age of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Severe depression or psychosis
2. Reduced cognition that would preclude active involvement and capacity to consent to participate
3. Unable to understand English

Recruitment start date

01/02/2018

Recruitment end date

30/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Ashford Hospital
London Road
Ashford
TW15 3AA
United Kingdom

Trial participating centre

St Peter’s Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom

Sponsor information

Organisation

Oxford Brookes University

Sponsor details

c/o Ms Kellie Tune
Marston Road Campus
Jack Straw’s Lane
Oxford
OX3 0FL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Parkinson's UK; Grant Codes: M6002

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Protocol publication in preparation for peer-reviewed journal. The results of the study are planned to be published in a peer reviewed journal around one year after the overall trial end date.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

11/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes