Activity Increase Despite Arthritis (AÏDA)

Design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]

Nefyn H. Williams, Elvis Amoakwa, Kim Burton, Maggie Hendry, John Belcher, Ruth Lewis, Kerenza Hood, Jeremy Jones, Paul Bennett, Rhiannon T. Edwards, Richard D. Neal, Glynne Andrew, Clare Wilkinson

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background. Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design. This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion. We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. Trial registration. Current Controlled Trials ISRCTN24554946.

Original languageEnglish
Article number62
JournalBMC Family Practice
Volume10
DOIs
Publication statusPublished - 7 Oct 2009

Fingerprint

Hip Osteoarthritis
Pamphlets
Knee Osteoarthritis
Arthritis
Randomized Controlled Trials
Exercise
Pain
Health Status
Fear
Hip
Knee
Outcome Assessment (Health Care)
Random Allocation
Psychometrics
General Practice
Health Care Costs
Health Services
Databases
Population

Cite this

Williams, Nefyn H. ; Amoakwa, Elvis ; Burton, Kim ; Hendry, Maggie ; Belcher, John ; Lewis, Ruth ; Hood, Kerenza ; Jones, Jeremy ; Bennett, Paul ; Edwards, Rhiannon T. ; Neal, Richard D. ; Andrew, Glynne ; Wilkinson, Clare. / Activity Increase Despite Arthritis (AÏDA) : Design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]. In: BMC Family Practice. 2009 ; Vol. 10.
@article{b4b6538671c149f295e6cd771775b7e7,
title = "Activity Increase Despite Arthritis (A{\"I}DA): Design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]",
abstract = "Background. Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design. This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion. We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. Trial registration. Current Controlled Trials ISRCTN24554946.",
author = "Williams, {Nefyn H.} and Elvis Amoakwa and Kim Burton and Maggie Hendry and John Belcher and Ruth Lewis and Kerenza Hood and Jeremy Jones and Paul Bennett and Edwards, {Rhiannon T.} and Neal, {Richard D.} and Glynne Andrew and Clare Wilkinson",
year = "2009",
month = "10",
day = "7",
doi = "10.1186/1471-2296-10-62",
language = "English",
volume = "10",
journal = "BMC Family Practice",
issn = "1471-2296",
publisher = "BioMed Central",

}

Activity Increase Despite Arthritis (AÏDA) : Design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]. / Williams, Nefyn H.; Amoakwa, Elvis; Burton, Kim; Hendry, Maggie; Belcher, John; Lewis, Ruth; Hood, Kerenza; Jones, Jeremy; Bennett, Paul; Edwards, Rhiannon T.; Neal, Richard D.; Andrew, Glynne; Wilkinson, Clare.

In: BMC Family Practice, Vol. 10, 62, 07.10.2009.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Activity Increase Despite Arthritis (AÏDA)

T2 - Design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]

AU - Williams, Nefyn H.

AU - Amoakwa, Elvis

AU - Burton, Kim

AU - Hendry, Maggie

AU - Belcher, John

AU - Lewis, Ruth

AU - Hood, Kerenza

AU - Jones, Jeremy

AU - Bennett, Paul

AU - Edwards, Rhiannon T.

AU - Neal, Richard D.

AU - Andrew, Glynne

AU - Wilkinson, Clare

PY - 2009/10/7

Y1 - 2009/10/7

N2 - Background. Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design. This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion. We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. Trial registration. Current Controlled Trials ISRCTN24554946.

AB - Background. Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. Methods/Design. This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. Discussion. We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial. Trial registration. Current Controlled Trials ISRCTN24554946.

UR - http://www.scopus.com/inward/record.url?scp=70349571163&partnerID=8YFLogxK

U2 - 10.1186/1471-2296-10-62

DO - 10.1186/1471-2296-10-62

M3 - Article

VL - 10

JO - BMC Family Practice

JF - BMC Family Practice

SN - 1471-2296

M1 - 62

ER -