Health Education Research, Vol. 19, No. 3, 316-325,
June 1, 2004
© 2004 Oxford University Press
An implementation study of two evidence-based exercise and health education programmes for older adults with osteoarthritis of the knee and hip
1 TNO Prevention and Health, Leiden, 2 Body@Work Research Center Physical Activity, Work and Health TNO-VUMC, Leiden/Amsterdam and 3 Academic Medical Center/Department of Social Medicine, University of Amsterdam, Amsterdam, The Netherlands 4 Correspondence to: O. R. W. de Jong; e-mail: ORW.deJong{at}pg.tno.nl
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Abstract |
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Implementation studies are recommended to assess the feasibility and effectiveness in real-life of programmes which have been tested in randomized controlled trials (RCTs). We report on an implementation study of two evidence-based exercise and health education programmes for older adults with osteoarthritis (OA) of the knee or hip. Three types of primary health-care providers (n = 18) delivered the OA Knee programme (n = 20) and the OA Hip programme (n = 20), supported by programme manuals and implementation guidelines, in four regions. The outcome measures were pain and mobility. The Knee programme had OA knowledge and self-efficacy as additional outcome measures. Differences in outcome measures and background variables of participants were assessed between the RCTs and the implementation study. Positive effects (P < 0.05) were found for OA knowledge, pain and self-efficacy in the Knee programme (n = 157), and for pain in the Hip programme (n = 132). No effect was found for mobility. Effect sizes of the RCTs and the present study were comparable. Background variables did not explain the variance in the outcome measures. The outcomes of the previous RCTs and the implementation study were comparable, and indicated the ecological validity of the two programmes. The implications for nationwide dissemination and implementation in The Netherlands are discussed.
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Introduction |
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TopAbstractIntroductionAn implementation study of...MethodsResultsDiscussionConclusions and recommendationsReferences |
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Evidence-based health education programmes, developed and tested in randomized controlled trials (RCTs), are often poorly diffused among practitioners and health-care providers, and have a modest reach in the population (Cameron et al., 1996
; King et al., 1998; Nutbeam, 1998; Prohaska et al., 2000). Large-scale adoption is improved if programmes are feasible and effective in real life (King, 1998; Prohaska et al., 2000). One controlled trial is not a sufficient basis to warrant the adoption of a programme (King et al., 1995) and implementation studies in different locations are needed to produce effective programmes. The outcomes of such studies facilitate the decision of policy makers, funding agencies and (health-care) providers to adopt programmes (Nutbeam, 1998; Øvretveit, 1998; Potvin, 1998). However, implementation studies differ from RCTs, and have implications for programme delivery, programme outcome and research design.
In an implementation study, providers have less control over programme delivery, often have fewer resources, and have more partners to cooperate and negotiate with than do investigators in a research study (Prohaska et al., 2000). They may need to re-design or adapt the contents and procedures of programmes for specific purposes and circumstances (Rogers, 1995). Yet when programme fidelity is violated, the outcome of RCTs and implementation studies cannot be compared. The focus of RCTs is to assess effectiveness in an effect evaluation, whereas implementation studies are a combination of process and effect evaluation, using triangulation of methods (Tones, 1997, 1999; Nutbeam, 1999). The characteristics of RCTs and implementation studies are given in Table I. We describe an implementation study of two programmes for older adults with osteoarthritis (OA) of the knee and hip.
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An implementation study of two OA programmes |
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OA is a common locomotor disorder which affects many older people. Because the population is ageing, it is a growing public health problem. The aim of OA treatment is to control the symptoms, such as pain, mobility problems and activity restrictions. TNO Prevention and Health in The Netherlands developed and tested in RCTs two programmes for older adults (55 years old and over) with OA of the knee or the hip (see ‘Exercise and health education programmes’ below). The OA Knee programme is a combination of physical exercise and health education. The programme is based on the Arthritis Self-Management Programme (Lorig and Fries, 1995
) and on the results of a problem analysis, which emphasized the role of physical activity and exercise for people with arthritic pain in the hip or knee (Hopman-Rock, 1997). The OA Hip programme is an innovative muscle-strengthening training programme using fitness equipment (Staats et al., 1997). Both programmes aim to stabilize mobility and to reduce pain. An additional aim of the Knee programme is to improve knowledge of OA and self-efficacy.
The outcomes of previous RCTs after 6 months showed that the OA Knee programme has a positive effect on OA knowledge, pain and self-efficacy (Hopman-Rock and Westhoff, 2000), and that the OA Hip programme has a positive effect on pain and hip function (Staats et al., 1999). Neither programme appeared to affect mobility. The duration of the programmes was thought to be too short to expect this kind of effect.
We considered the results of the RCTs to justify the setting up of an implementation study. The objective was to assess the feasibility and effectiveness of the programmes in real-life conditions. A positive outcome should facilitate the decision of primary health-care providers to adopt the programmes on a large scale.
A process and effect evaluation was carried out. The outcomes of the process evaluation showed that both programmes were feasible and attainable at a provider level (de Jong et al., 2002). This article describes the results of the effect evaluation in terms of OA knowledge, self-efficacy, mobility and pain. Furthermore, we assessed differences in the outcome measures and differences in the characteristics of the programme participants (background variables) between the implementation study and the RCTs.
Exercise and health education programmes
The Knee and Hip programmes were both developed as a result of studies of health and quality of life problems among patients with OA (Hopman-Rock, 1997; Staats et al., 1997).
OA Knee programme
The OA Knee programme consists of a combination of moderate physical exercises and extensive health education and is based on cognitive behavioral and social learning theories (Tak et al., 1999). The programme consists of six weekly sessions of 2 hours, with a maximum of 15 participants. In each session, 1 hour is spent on health education: information on osteoarthritis; lifestyle and physical activity; weight control and dieting; pain management; coping with activity restriction; medical issues. The health education is delivered by a peer educator in a interactive way. Peer education is recognized to have an empowerment effect (Garcia et al., 1997; Petty and Cusack, 1998). The second hour is spent on exercises with moderate intensity and supervised by a qualified physiotherapist. Participants receive a course book, including a home-based exercise programme.
OA Hip programme
The OA Hip programme consists of muscle strengthening training schedules, using fitness equipment, combined with limited health education and with ergonomic advice at home (Staats et al., 1999). It consists of nine weekly sessions of 1 hour, with a maximum of 12 participants. The first session is spent on health education (life style information, OA and physical activity), delivered by a physiotherapist and an occupational therapist. During the remaining sessions, participants train with fitness equipment to strengthen hip function. The training is supervised by two physiotherapists. At study entry, muscle strength is measured and training programmes are tailored to individual needs and capacity. Nine pre-defined apparatuses are used or, if not available, alternative ones with the same function. The occupational therapist carries out home visits on request to advise about ergonomic issues at home. The participants receive written instructions for a home-based exercise programme.
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Methods |
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Selection of providers and requirements of programme delivery
Three types of primary health-care providers were eligible for participation: commercial PhysioSport Centers, local health centers and the health service departments of home-care organizations. The home-care organizations provide long-term, home-based care to chronically ill, handicapped and elderly in need.
Four pilot regions were selected—two urban and two semi-rural areas in western and central Netherlands. The project budget was sufficient for a maximum of 20 providers. Individual providers were contacted by telephone. Each provider was assigned a contact person who received instruction training and written guidelines for the local implementation of the programmes, and manuals for programme delivery.
Because fidelity and completeness of programme delivery are predictors of effectiveness (Rossi et al., 1999), both the implementation guidelines and the programme manuals consisted of instructions for programme planning and delivery. Providers could adjust the programme content and procedures, provided that they did not change the core components. Allowing providers to make adjustments, e.g. a certain degree of programme refinement, enhances commitment, and ensures complete and conscientious delivery of the core components (Rogers, 1995).
Selection procedure of programme participants
The recommended selection procedure, including the inclusion and exclusion criteria, was described in the implementation guidelines. The programme participants were recruited by providers by means of announcements in local newspapers, in monthly magazines of the home-care organizations and through recommendations of GPs. Adults aged 55 years or older with OA of knee or hip were eligible for participation. The physiotherapist used an assessment protocol, including a decision tree, to assess eligibility. The protocol was based on the criteria of the American College of Rheumatology, which are also applied by Dutch general practitioners. All applicants whose OA of the knee or hip was diagnosed by a GP were included. Applicants with self-reported OA of the hip were only included if they reported pain at endorotation of the hip and morning stiffness, but no other major health problems. Applicants with self-reported OA of the knee were included if they reported crepitation, swelling and stiffness of one or both knee joints, but no other major health problems.
Applicants with symptoms of OA of both knee and hip could participate in one of the programmes, depending on the severity of the symptoms of either knee or hip. Applicants on a waiting list for knee or hip replacement and/or with self-reported severe mobility problems were excluded from participation.
Measurements
All participants completed questionnaires before and after the programme. This pre-test/post-test design was thought to be adequate, given the objective to identify the effects of the programmes in real-life conditions after the initial RCTs.
Outcome measures were pain, mobility, self-efficacy and OA knowledge for the Knee programme, and pain and mobility for the Hip programme. Self-efficacy and OA knowledge were not evaluated, because the Hip programme is a muscle-strengthening training programme. The patients with combined OA of the knee and hip were evaluated according to the programme they followed. Questions on background variables were asked about sex, age, civil status, education, income and the number of other chronic conditions. OA knowledge in the Knee programme was assessed by means of 20 statements (range 0–10). A higher score indicates more correctly answered questions.
Self-reported pain was assessed with five items of the Impact of Rheumatic Diseases on General Health and Lifestyle (IRGL) pain scale (Huiskes et al., 1990). The IRGL is based on the Arthritis Impact Measurement Scales I (Meenan, 1986), but adapted to the Dutch situation. Measured parameters were severity, tolerance and frequency of pain (range 5–25; Cronbach’s 
0.86). A higher score indicates more pain. Furthermore, tolerance and severity of pain were measured over the past month with a Visual Analogue Scale (VAS; range 0–100). A higher score indicates less tolerance and more severe pain. Mobility in both programmes was measured with seven items of the IRGL mobility scale (range 7–28; Cronbach’s 0.92). A higher score means better mobility. Self-efficacy, one’s belief that one can perform a specific task or behavior in the future, was measured with the Dutch version of Lorig’s efficacy scale for controlling the OA symptoms of pain, daily functioning and other symptoms (range 0–5 each; Cronbach’s 0.76–0.89) (Lorig et al., 1989). A higher score reflects better self-efficacy.
Statistical analyses
Paired t-tests were used to test for differences between pre-test and post-test scores. To test for differences in the background variables of participants in the RCTs and the implementation study, the t-test for means of two groups and the 
2-test for nominal variables were used. A stepwise regression analysis for each programme was carried out to identify the characteristics of participants which may have predicted the effects. For the Knee programme, a combined outcome parameter was constructed from the parameters knowledge, pain (IRGL and VAS), self-efficacy and mobility (IRGL) with a range from 6 (no effect) to 12 (positive effect). For the Hip programme, a similar procedure was followed for the parameters pain and mobility. Independent variables in the analysis for the Knee programme were age, civil status, income, education and number of chronic conditions. In the Hip programme all variables were included, except for income (not measured in the RCT).
An individual effect size was used to assess the changes in the outcome parameters in the Knee programme. It was also used to compare the effect sizes of the RCT of this programme. The effect size of the Hip programme and that of the RCT was not compared, because in the RCT the outcome parameters mobility and pain were not measured with the IRGL and VAS, but with the Harris Hip Score.
For all analyses, a significance level of < 0.05 was used.
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Results |
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Table II provides an overview of the total number of Knee and Hip programmes carried out, in combination with the types of providers. Eighteen providers participated. Two providers decided to withdraw after initial cooperation. In total, 204 participants attended the Knee programme and 169 participants the Hip programme. Questionnaires were completed by 177 participants (87%) of the Knee programme and by 153 participants (91%) of the Hip programme. Accurate information on the completion and return of the post-test questionnaires to TNO by the providers is not available. For approximately 50% of the participants, it took providers of the Knee programme on average 49 days and those of the Hip programme on average 71 days to return the post-test data to TNO.
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Inclusion criteria for the analysis were for both programmes age (55 years or older) and attendance (for the Knee programme minimum attendance of four out of six sessions and for the Hip programme attendance of six out of nine sessions). In the Knee programme, 20 people and in the Hip programme, 21 people did not meet the age and attendance criteria. In total, the data from 157 participants (77%) of the Knee programme were included in the analysis and 132 participants (78%) of the Hip programme.
Outcome parameters
Tables III and IV present the results for the outcome parameters. Both programmes had a positive effect on pain, measured with the IRGL subscale, and on pain severity and pain tolerance, measured with the VAS. For self-efficacy, the Knee programme had a positive effect on the subscale pain only. It had a positive effect on OA knowledge. Neither programme affected mobility. Effect size for OA knowledge (Knee programme) was considerably lower in the implementation study than in the RCT (Table V), but for the other outcome parameters, the effect sizes were comparable between the two studies.
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Background variables of programme participants
The characteristics of both groups are shown in Table VI, in combination with the data of the RCTs. The participants of the Knee programme were significantly older in the implementation study than in the RCT (t = 3.98, P = 0.000), unlike the participants of the Hip programme (t = 0.92, P = 0.357). The number of chronic conditions was significantly higher in the implementation study than in the RCTs in both the Knee programme (t = 5.67, P = 0.000) and in the Hip programme (t = 2.83, P = 0.005). Level of income of the Knee programme participants was significantly higher in the implementation study (
2 = 7.41, P = 0.025), than in the RCT; it was not measured for the Hip programme. Participant level of education did not differ in the Knee programme (2 = 3.84, P = 0.147), but was significantly higher in the Hip programme in the implementation study (2 = 2.83, P = 0.009). Sex and civil status of the participants in both programmes did not differ significantly.
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The regression analysis for both programmes showed that none of the participant characteristics explained the variance in the combined outcome parameter.
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Discussion |
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Outcome parameters
The results for OA knowledge and self-efficacy (OA Knee programme) and pain (both programmes) are encouraging, compared with the outcomes of the RCTs—especially taking into account that the intended ‘natural setting’ of programme delivery was somewhat artificial, because the participants were still subjected to a research context, which may have influenced their response. We would like to stress, however, that we tried to minimize the spurious elements in the project as much as possible. The research team had no contact with the participants. Contact with the providers was also minimal. Providers planned, organized and delivered the programmes with the assistance of written guidelines after a short instruction meeting. Nevertheless, participants were informed about the research context by the providers, who also distributed and collected the questionnaires.
The findings are in line with those of similar programmes for older adults with OA: the Fitness Arthritis and Seniors Trial (Ettinger et al., 1997), the Arthritis Self-Management Programme (Lorig and Fries, 1995; Barlow et al., 1997, 1999), the Program of Supervised Fitness Walking and Supportive Patient Education (Sullivan et al., 1998), and the Tai Chi Training on Function and Quality of Life Indicators (Hartman et al., 2000). Positive effects on pain and self-efficacy were reported, whereas the effects on mobility were inconsistent, with either no effect or modest effects being reported.
It may be too ambitious to expect an exercise programme to improve mobility, as shown in the Longitudinal Aging Study Amsterdam (Visser et al., 2002). Mobility deteriorated more in older adults with chronic conditions and with an inactive lifestyle than in older adults with chronic conditions who participated in sports activities and otherwise had an active lifestyle. In our study, the mobility did not diminish with either programme, which may be perceived as a positive effect. Effects on mobility may also be limited by the relatively short duration of the programmes, the low frequency of the sessions and the relatively low intensity of the exercises. For effects on mobility, a higher frequency and intensity may be required, but such programmes may carry a higher risk of injury (Ettinger et al., 1997).
Profile of participants
More women participated in the programmes than men, which is consistent with the higher prevalence of OA in women (van Saase et al., 1999). In the implementation study, participants had more chronic conditions than did participants in the RCTs and the participants in the Knee programme were significantly older. This reflects the enrolment strategy. Most participants had applied to join the programmes via announcements in the regional periodicals of the home-care organizations. Most people using home-care are elderly and, thus, are expected to have more chronic conditions.
Participant characteristics did not explain the variance in the combined outcome parameter. Thus, the participants, regardless of their characteristics, benefited to an equal extent from programme participation. From an implementation point of view, the inclusion and exclusion criteria for participation in the programmes do not need to be adjusted.
Adherence to exercise
Although monitoring adherence to the exercise regimen was not part of the implementation study, it was a major issue in the experimental studies of both programmes. Immediately after completion of the programmes, the participants reported an increase in their overall physical activity, but this effect disappeared after 6 months.
Compliance is a general problem with respect to exercise programmes for older adults with OA. Compliance was good during an 18-month period of Aerobic Exercise Training and Resistance Exercise Training for older adults with OA of the knee (Ettinger et al., 1997). However, this may have been due to the rather intensive and frequent supervision offered to the participants. Positive effects on pain and self-efficacy in a RCT of the supervised fitness-walking programme for patients with OA of the knee were no longer detected after 1 year, because of a lack of compliance (Sullivan et al., 1998). Patients with OA also tend not to adhere to individual exercise therapy (van Baar et al., 1999; Campbell, 2001). Compliance is improved by frequent contact with the physiotherapist. Long-term effects can only be expected when compliance with the exercise programme is good. In the future, primary health-care providers will be advised to carry out follow-up activities with participants by telephone contacts in order to stimulate them to keep physically active. Regular telephone contact has proved to be effective with respect to the self-management of patients with OA (René et al., 1992).
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Conclusions and recommendations |
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The outcomes of the previous RCTs and the implementation study are comparable, and indicate ecological validity of both programmes (Glanz et al., 1997
). Ecological validity means the ability of programmes, tested under controlled conditions, to produce comparable outcomes in real-life conditions. In particular, the decrease of pain is a noticeable effect. Pain is an indicator of perceived quality of life and a reason to consult the GP.
We identified two explanations for the clinical and behavioral outcomes. The process evaluation indicated that the providers delivered the programmes as intended and programme fidelity was, thus, ensured (de Jong et al., 2002). As stated before, programme fidelity is a predictor of effectiveness. Additionally, both programmes complied with the predictive criteria for effectiveness of health education programmes: individualization, feedback on progress, reinforcement and facilitation (Mullen et al., 1992). Both OA programmes deliver information on OA in an interactive way, tailor-made to the needs and demands of participants, and dealing with personal questions. The exercises are carried out according to an individual’s capacity and physical limitations. Progress is monitored by means of regular verbal and written feedback on exercise performance. Programme participation is reinforced by the perceived positive effect on self-efficacy. In both programmes, participants are provided with and trained in the use of a home-based exercise programme.
Implications for nationwide implementation
All stakeholders, the national organizations of providers, the providers themselves and the co-financing health insurers, concluded that the programmes are relevant and feasible for their supply of health services to elderly people. Large-scale implementation was recommended, with special attention being given to pro-active follow-up to stimulate adherence to the exercise regimen and a cost–benefit analysis of the programmes. In due course, both programmes will be implemented in the Dutch primary health-care system, supported by continuing monitoring of the implementation process and the outcomes.
Links between researchers, policy makers and practitioners
The implementation study was carried out within the context of facilitating the decision of providers, policy makers and funding agencies to adopt the programmes. This context lies at the heart of implementation studies. Such studies bridge the gap between research, policy making and practice. While experimental research focuses on the effectiveness of programmes, practitioners, providers and policy makers require relevant facts about actual implementation issues. Implementation studies emphasize that planned cooperation between researchers, practitioners and policy makers can contribute to the transfer of research results. In doing so, the widely recognized gap between research and practice can be bridged.
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Acknowledgements |
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This study was supported by grants from several Dutch organizations: ZonMw/Netherlands Organization for Health Research and Development, the Province of Noord-Brabant, the Dutch Arthritis Association, and TNO Prevention and Health. Four health insurance companies supported the project financially: Zilveren Kruis/Achmea, CZ Group, VGZ and OZ. Close cooperation took place with the Brabant Institute for Care and Welfare (BOZ).
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Received on November 7, 2002; accepted on April 19, 2003
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