Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial)
Introduction Persistent non-cancer pain affects one in five adults and is more common in Māori—the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), acc...
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2021-02-01
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| author | Anthony Dowell Sarah Gerard Dean Leigh Hale Andrew R Gray Tristram Ingham Bernadette Jones Cheryl Davies Rebecca Grainger William Leung Meredith Perry Hemakumar Devan Dagmar Hempel Jessica Mills Barbara Saipe Edward Shipton |
| author_facet | Anthony Dowell Sarah Gerard Dean Leigh Hale Andrew R Gray Tristram Ingham Bernadette Jones Cheryl Davies Rebecca Grainger William Leung Meredith Perry Hemakumar Devan Dagmar Hempel Jessica Mills Barbara Saipe Edward Shipton |
| author_sort | Anthony Dowell |
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| description | Introduction Persistent non-cancer pain affects one in five adults and is more common in Māori—the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), access to PMPs is poor due to long waiting lists. Although online-delivered PMPs enhance access, none have been codesigned with patients or compared with group-based, in-person PMPs. This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a cocreated, culturally appropriate, online-delivered PMP (iSelf-help) compared with in-person PMP in reducing pain-related disability.Methods and analysis Mixed-methods, using a modified participatory action research (PAR) framework, involving three phases. Phase I involved cocreation and cultural appropriateness of iSelf-help by PAR team members. Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. Adults (n=180, age ≥18 years) with persistent non-cancer pain eligible for a PMP will be recruited and block randomised (with equal probabilities) to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help participants will participate in two 60-minute video-conferencing sessions weekly for 12 weeks with access to cocreated resources via smartphone application and a password-protected website. The control participants will receive group-based, in-person delivered PMP. Primary outcome is pain-related disability assessed via modified Roland Morris Disability Questionnaire at 6 months post intervention. Secondary outcomes include anxiety, depression, stress, pain severity, quality of life, acceptance, self-efficacy, catastrophising and fear avoidance. Data will be collected at baseline, after the 12-week intervention, and at 3 and 6 months post intervention. We will conduct economic analyses and mixed-method process evaluations (Phase IIA).Ethics and dissemination The Health and Disability Ethics Committee approved the study protocol (HDEC18/CEN/162). Phase III involves dissemination of findings guided by the PAR team as outcomes become apparent.Trial registration number ACTRN 12619000771156. |
| format | Article |
| id | doaj-art-fab5ed13b45b4f55a8bb990e18d04e5d |
| institution | Kabale University |
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| language | English |
| publishDate | 2021-02-01 |
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| spelling | doaj-art-fab5ed13b45b4f55a8bb990e18d04e5d2024-11-17T09:10:09ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-046376Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial)Anthony Dowell0Sarah Gerard Dean1Leigh Hale2Andrew R Gray3Tristram Ingham4Bernadette Jones5Cheryl Davies6Rebecca Grainger7William Leung8Meredith Perry9Hemakumar Devan10Dagmar Hempel11Jessica Mills12Barbara Saipe13Edward Shipton145 Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand2 Medical School, University of Exeter, Exeter, UK2 School of Physiotherapy, Division of Health Sciences, University of Otago, Dunedin, New ZealandBiostatistics Centre, Division of Health Sciences, University of Otago, Dunedin, New Zealand1 Department of Medicine, University of Otago, Wellington, New Zealand1 Department of Medicine, University of Otago, Wellington, New Zealand3 Wessex Academic Health Science Network, Chilworth, UK4 Department of Medicine, University of Otago, Wellington, New Zealand11 Department of Health Economy, Wellington School of Medicine, University of Otago, Wellington, New ZealandCentre for Health Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand2 Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, Wellington, New Zealand8 Pain Management Service, Capital and Coast District Health Board (CCDHB), Wellington, New Zealand10 Burwood Pain Management Service, Canterbury District Health Board (CDHB), Christchurch, New Zealand8 Pain Management Service, Capital and Coast District Health Board (CCDHB), Wellington, New Zealand11 Department of Anaesthesia, University of Otago, Christchurch, New ZealandIntroduction Persistent non-cancer pain affects one in five adults and is more common in Māori—the Indigenous population of New Zealand (NZ), adults over 65 years, and people living in areas of high deprivation. Despite the evidence supporting multidisciplinary pain management programmes (PMPs), access to PMPs is poor due to long waiting lists. Although online-delivered PMPs enhance access, none have been codesigned with patients or compared with group-based, in-person PMPs. This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a cocreated, culturally appropriate, online-delivered PMP (iSelf-help) compared with in-person PMP in reducing pain-related disability.Methods and analysis Mixed-methods, using a modified participatory action research (PAR) framework, involving three phases. Phase I involved cocreation and cultural appropriateness of iSelf-help by PAR team members. Phase II: The proposed iSelf-help trial is a pragmatic, multicentred, assessor-blinded, two-arm, parallel group, non-inferiority randomised controlled trial. Adults (n=180, age ≥18 years) with persistent non-cancer pain eligible for a PMP will be recruited and block randomised (with equal probabilities) to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help participants will participate in two 60-minute video-conferencing sessions weekly for 12 weeks with access to cocreated resources via smartphone application and a password-protected website. The control participants will receive group-based, in-person delivered PMP. Primary outcome is pain-related disability assessed via modified Roland Morris Disability Questionnaire at 6 months post intervention. Secondary outcomes include anxiety, depression, stress, pain severity, quality of life, acceptance, self-efficacy, catastrophising and fear avoidance. Data will be collected at baseline, after the 12-week intervention, and at 3 and 6 months post intervention. We will conduct economic analyses and mixed-method process evaluations (Phase IIA).Ethics and dissemination The Health and Disability Ethics Committee approved the study protocol (HDEC18/CEN/162). Phase III involves dissemination of findings guided by the PAR team as outcomes become apparent.Trial registration number ACTRN 12619000771156.https://bmjopen.bmj.com/content/11/2/e046376.full |
| spellingShingle | Anthony Dowell Sarah Gerard Dean Leigh Hale Andrew R Gray Tristram Ingham Bernadette Jones Cheryl Davies Rebecca Grainger William Leung Meredith Perry Hemakumar Devan Dagmar Hempel Jessica Mills Barbara Saipe Edward Shipton Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) BMJ Open |
| title | Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) |
| title_full | Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) |
| title_fullStr | Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) |
| title_full_unstemmed | Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) |
| title_short | Clinical and cost-effectiveness of an online-delivered group-based pain management programme in improving pain-related disability for people with persistent pain—protocol for a non-inferiority randomised controlled trial (iSelf-help trial) |
| title_sort | clinical and cost effectiveness of an online delivered group based pain management programme in improving pain related disability for people with persistent pain protocol for a non inferiority randomised controlled trial iself help trial |
| url | https://bmjopen.bmj.com/content/11/2/e046376.full |
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