PARTICIPANT INFORMATION AND CONSENT FORM

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1 PARTICIPANT INFORMATION AND CONSENT FORM STUDY TITLE: Reducing long-term disability related to pain: A randomised controlled trial of the Pain Disability Prevention Programme (PDP) in the Irish health service. NAME OF PRINCIPAL INVESTIGATORS: Dr. Brian McGuire & Ms. Miriam Raftery, Centre for Pain Research, NUI Galway. Ms. Jessica Dudley, Clinical Psychologist, North Lee Primary Care Team, Cork. You are being invited to participate in a research study. Thank you for taking time to read this. WHAT IS THE PURPOSE OF THIS STUDY? The aim of the study is to test the effectiveness of a pain rehabilitation programme called Pain Disability Prevention Programme (PDP). This programme aims to help patients with back pain to manage their pain and gradually increase their level of activity. We want to test the effectiveness of the programme. We will do this by comparing two groups of patients: one group who receive their usual medical care plus the PDP intervention (Intervention Condition) and another group who receive medical care as usual only (Control Condition). WHY HAVE I BEEN CHOSEN? You have been chosen because you experience back pain and you are unable to work or are on reduced work hours due to your pain. You may be suitable to take part in this study. WHAT WILL HAPPEN IF I VOLUNTEER? If you agree to participate, you will be requested to complete the enclosed consent form. Your GP will also need to sign this consent form. You will then be asked to complete a questionnaire. This questionnaire will be posted to you at home. This will take about 20 minutes to complete. After you have returned the questionnaire you will be contacted by the researcher to let you know if you are suitable to take part in the study. Your suitability will be based on your particular level of disability. This is a randomised trial which means that if you are suitable to take part in the research, you will be randomly assigned to one of two conditions: the intervention condition or the control condition. 1

2 WHAT HAPPENS IF I AM PART OF THE INTERVENTION CONDITION? If you are assigned to the intervention condition you will take part in the Pain Disability Prevention Programme. The effectiveness of this intervention is being trialled as part of this research study. It will involve a maximum of 10 weekly one-to-one meeting with the psychologist who is trained in pain management. These meetings will last 1 hour and will take place in Mayfield, Cork. Sessions will involve active rehabilitation, instruction in a range of pacing techniques, cognitive therapy to help identify negative thinking patterns and the development of effective challenges, stretching and exercising to improve physical function. You will still receive your medical care as usual and you are free to access additional services if you wish (e.g. private physiotherapy etc). You will be asked to complete a questionnaire booklet at the end of the 10 week programme. You will also be sent another questionnaire after 12 months. These questionnaires will take about 20 minutes to complete. Please note, you will be asked to complete a diary of activity between sessions. If you have any difficulty with reading or writing or simply do not feel comfortable reading or writing, please let your clinician know at your first appointment and alternative arrangements can be made. WHAT HAPPENS IF I AM PART OF THE CONTROL CONDITION? If you are assigned to the control condition you will not receive the Pain Disability Prevention Programme. No aspect of your usual care will be affected. You will be asked to complete a questionnaire after 10 weeks and again after 12 months. These questionnaires will take about 20 minutes to complete. This comparison information will help us decide if the intervention is effective for people with pain. ARE THERE ANY BENEFITS FROM MY PARTICIPATION? If you are part of the intervention condition you will have the opportunity to have a maximum of 10 one-to-one sessions with a psychologist trained in pain rehabilitation. This will be provided free of charge and will take place over the course of weeks. This may help you to structure your activities and improve your level of activity. If you are part of the control condition you will not benefit directly from taking part in this study. However the information we will obtain may provide further knowledge of the effectiveness of this programme for people with pain. ARE THERE ANY RISKS INVOLVED IN PARTICIPATING? As part of this study you will be asked to complete a questionnaire booklet at 3 different time points. This will include questions that ask about your feelings and well-being now and in the recent past. For some people this may be upsetting. You might find while you are answering them that you would like to talk to someone about some of the issues raised. We will be happy to recommend someone. 2

3 WHAT HAPPENS IF I DO NOT AGREE TO PARTICIPATE? Your participation is entirely voluntary. If you decide not to participate in this study your treatment will not be affected in any way. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect your rights in any way. Furthermore your doctor may decide to withdraw you from this study if he/she feels it is in your best interest. CONFIDENTIALITY Your identity will remain confidential. A study number will identify you. Your name will not be published or disclosed to anyone. WHO IS ORGANISING AND FUNDING THIS RESEARCH? This study is organised by NUI Galway. It is funded by the Health Research Board. WILL I BE PAID FOR TAKING PART IN THIS STUDY? No. WILL MY EXPENSES BE COVERED FOR TAKING PART IN THIS STUDY? No. If you are part of the intervention condition, you will have to pay for travel to and from your appointments with the local pain management psychologist. These expenses will not be covered by the research team. HAS THIS STUDY BEEN REVIEWED BY AN ETHICS COMMITTEE? University College Cork, Research Ethics Committee have reviewed and approved this study. CONTACT DETAILS If you would like any further information about the study, without any obligation to take part, please contact: The research co-ordinator: Ms. Miriam Raftery, Dept of Clinical Psychology, National University of Ireland, Galway. Tel: Or the principal Investigator: Dr. Brian McGuire, Centre for Pain Research, National University of Ireland, Galway. Tel:

4 Participant Consent Form Pain Disability Prevention Study. 1. I confirm that I have received a copy of the Information Sheet for the above study. I have read it and I understand it. I have received an explanation of the nature, purpose, duration and foreseeable effects and risks of the study and what my involvement will be. 2. I have had time to consider whether to take part in this study and I have had the opportunity to ask questions. 3. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 4. I understand that my consultant will be informed that I am taking part in this study. 5. I agree to take part in the above study. Yes No Patient name Date Signature Patients Address: Patient contact number: Please return both consent forms (pages 4 &5) in the postage paid envelope or return to: Miriam Raftery, Centre for Pain Research, School of Psychology, NUI Galway. Thank you. 4

5 GP/Consultant Consent Form Pain Disability Prevention Study. Patients Name: Date of Birth: As the above patients consultant/gp, I confirm that this patient is medically suitable to take part in the Pain Disability Prevention Trial. If suitable the patient may be able to access a maximum of 10 sessions of active rehabilitation supported by a CBT-based approach. Sessions take place in Mayfield, Cork. I agree to this patient taking part in the study Yes No Name of consultant/gp Date Signature Consultant/GP Address: Contact no: Please return both consent forms (pages 4 &5) in the postage paid envelope or return to: Miriam Raftery, Centre for Pain Research, School of Psychology, NUI Galway. Thank you. 5

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