The aim of this study is to investigate the cost-effectiveness of E-Exercise in comparison with usual care of a physical therapist. Research question for this RCT study is: What are the short- (3 months) and long term (12 months) (cost) effects of E…
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Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical functioning will be assessed with the subscale *function in daily
living* of the Hip Osteoarthritis Outcome Score (HOOS) and/or the Knee Injury
and Osteoarthritis Outcome Score (KOOS). The HOOS and the KOOS assess 5
indicators: pain, symptoms, physical function, sport and recreation function
and quality of life, in relation to patients* hip or knee complaint. Each
indicator is scored on a 5-point Likert scale (0=extreme symptoms; 4=no
symptoms)
Physical activity will be measured with the SQUASH. The questionnaire measures
habitual physical activity during a normal week over the last few months. The
total score is reproduced as minutes per week , but data can also be analysed
according to whether the activity is light, moderate or intense.
Objective physical activity will be measured through ActiGraph GT3X tri-axial
accelerometers. Patients will be instructed to wear the monitor on a belt
around their waist for five executive days, except during sleeping, showering
or swimming. In addition, participants will be requested to fill out a short
activity diary. This diary contains questions about wearing time, unusual
activities and reasons for device removal. When accelerometers and diaries are
returned by post, data can be downloaded, processed and subsequently analyzed.
In order to determine the actual physical activity thresholds, the widely
accepted thresholds by Freedson et al. will ge used: 0-99 counts for sedentary
activities, 100-1951 for light PA, 1952-5724 moderate physical activity,
5725-9498 for vigorous PA and 9499- max for very vigorous activities. The total
time spent in light, moderate and (very) vigorous physical activity was summed
and subsequently divided by the number of days worn to compute the daily
average time spent in total activity. For analysis, data were recorded at
1-minute intervals.
Secondary outcome
OA related costs made by the patients will be registered with an online cost
diary. Patients will be asked to register their direct costs of OA within and
outside the health care sector and on the indirect costs of productivity loss.
The cost diary will cover the full 12 months of the program.
Health Related Quality Of Life will be measured with the EuroQol-5D
(EQ-5D).(35) This questionnaire comprises 5 dimensions i.e., mobility,
self-care, usual activities, pain/discomfort and anxiety/depression. Patients
are asked to indicate their health state on a 3-point Likert scale (1=no
problems; 3=extreme problems). The questionnaire enables 245 different health
states. Each health state can be ranked and transformed to a score which is
defined as utility. The utility score is an expression of the quality adjusted
life years (QALY*s).
Self-perceived effect will be assessed by a single question about the degree of
change in physical functioning since their previous assessment. Patients can
score this effect on a 7-point Likert scale (1=much worse; 7= much better).
Pain and tiredness will be measured with a numeric rating scale(NRS; 0 is no
pain/not tired and 10 is worst possible pain/very tired) (NRS; 0=no problems;
10=extremely problems). Furthermore, pain will be assessed with the pain
subscale of the HOOS and/or the KOOS.
Self-efficacy will be measured by the Arthritis Self-efficacy Scale (ASES).(36)
Subscales for the ASES are pain, symptoms and physical functioning, the 19
statements can be scored on a 5 point-Likert scale (1=fully disagree; 5=fully
agree).
Self-management skills will be measured through the Health Education Impact
Questionnaire (HeiQ).(37) The questionnaire consists of 40 questions statments
subdivided in 8 scales i.e., health directed behaviour, positive and active
engagement in life, emotional well-being, self-monitoring and insight,
constructive attitudes and approaches, skill and technique acquisition, social
integration and support and health service navigation. The 40 statements can be
scored on a 4 point-Likert scale (1=fully disagree; 4=fully agree).
Depression and Anxiety will be measured by the Hospital Anxiety and Depression
Scale (HADS).(39) 7 items are related to depression and 7 items to anxiety. The
statements can be scored on a 4 point-Likert scale (0-3). A lower score
represents less anxiety and depression, the cut-off point for depression and
anxiety is 8 points.
Background summary
Among the elderly, osteoarthritis (OA) is worldwide one of the leading causes
of pain and disability. Most common affected sites are the hip and knee (Issa,
2013). In the Netherlands, it is estimated that 312.000 persons suffer from
knee OA and 238.000 from hip OA (Poos, 2009) OA is an age-related
disease(Zhang, 2010) and besides pain and disability, characterized by morning
stiffness, reduced range of motion, instability of the joint,(Poos, 2009) loss
of health related quality of life(Salaffi,2005) and mortality (Nüesch, 2010).
Due to the aging population and the increasing number of people with obesity,
expected prevalence of knee and hip OA is 52% in 2040. Healthcare costs related
to OA were about 715 million euro in 2007, which was 14.4% of total healthcare
costs of musculoskeletal diseases in The Netherlands (Poos, 2009) .In order to
regulate these costs while the population with OA is growing, there is a need
for cost-effective interventions.
Because of OA related clinical symptoms people with hip and/or knee OA are less
physically active than the general population (De Groot, 2008, Rosemann 2013).
Where symptoms of OA results in less physical activities, in long term physical
inactivity may lead to physical decline, psychological problems and eventually
functional decline (Dunlop, 2006; Pisters, 2012).Since research showed that
physical activity is beneficial for reducing pain and improvement of physical
functioning (Dunlop2011), physical activity is widely recommended by national
and international (physical therapy) guidelines (Zhang,2008)
Besides physical activity, information and self-management are recommended in
order to improve physical functioning (Zhang, 2008; Peter, 2010. The inclusion
of information is important since a lack of knowledge among OA patients
appeared to be related to depression, anxiety and a passive coping style
(Lorig. 1993). Self-management appeared to reduce disability and health related
costs as in doctor visits and hospitalization (Warsi 2003;Lorig, 1993; Lorig,
1999). The ultimate goal of the physical therapy sessions for patients with OA
is to increase patients* knowledge and amount of physical activity in order to
improve physical functioning. Final aim is that patients maintain a physically
active lifestyle without supervision of physical therapist (Köke, 2011).
With the explosion of internet accessibility, the internet has created new
possibilities to support physical therapists in the treatment of OA patients.
In a review of Pietrzak et al., internet interventions in patients with OA
resulted in improvement of health status, access to care and communication
between patients and health professionals (Pietrzak, 2013). Financially, it is
likely that less face-to-face contact with a professional may result in lower
costs. Besides, a cheaper intervention would make OA treatment accessible for
patients without sufficient insurance (Marcus, 2009). By substitute a part of
the face-to-face contacts with a physical therapist by a website, a combination
of *the best of two worlds* will be generated (Van Gemert, 2013).
To date, there are no studies about the (cost) effectiveness of blended care
initiatives in the field of knee and/or hip osteoarthritis. We therefore have
planned to evaluate E-Exercise, which is an integration of face-to-face
sessions by a physical therapist and a web-based intervention. The web-based
part will be based on the online program Join2Move (Bossen, 2013), since this
program showed to be effective in improvement of physical functioning and
physical activity in patients with knee and/or hip OA.
Study objective
The aim of this study is to investigate the cost-effectiveness of E-Exercise in
comparison with usual care of a physical therapist. Research question for this
RCT study is: What are the short- (3 months) and long term (12 months) (cost)
effects of E-Exercise in patients with knee and/or hip OA on physical activity
and physical function in comparison with a face-to-face physical therapy
intervention?
Study design
We will perform a clustered randomized controlled clinical trial will be
performed. Patients with osteoarthritis of hip or knee will be randomly
assigned to either the E-Exercise intervention or the physical activity program
provided by physical therapists (usual care). Patients who are assigned to the
usual care will be offered to participate in the E-Exercise program after the
study has been finished (after 12 months without guidance of a physical
therapist).The study period of each patient is 12 months. During these 12
months three assessments will be performed, at baseline, after 3 months and 12
months.
Intervention
The intervention group will receive the 12-week E-Exercise program. E-Exercise
a combination of four to five face-to-face sessions with a physical therapist
and a web-based intervention. The content is written according to the KNGF
guideline Osteoarthritis Hip-Knee (Peter, 2010).Tailored modules are weekly
presented on the website E-Exercise. A module consists of three topics. (i)
Information; various topics will be discussed (e.g. OA, physical activity,
pain, medication, nutrition etc.) through texts and videos.( ii) Graded
Activity; a selected activity will be increased on a weekly basis. Based on a
short term goal, a tailored schedule of modules is generated on a
time-contingent basis. The gradual increase of the selected activity starts
slightly below the baseline value and increases incrementally towards a short
term goal. This part of the intervention is derived from a previous developed
and evaluated behavioral graded activity (BGA) program for patients with knee
and/or hip OA (Veenhof 2006). The gradual increase in activities aims to
improve physical activity levels despite the potential presence of pain. (iii)
Strength and mobility exercises; each module contains specific exercises which
are provided through videos.
When a patient visits, for the first time, the physical therapy practice the
therapists will carry out an anamnesis, physical examination and a clinical
test to confirm clinical knee and/or hip OA. Moreover, the physical therapist
will also assess other in- and exclusion criteria. Eligible and interested
patients will contact the research team to participate in the study. The
following week after the intake is dominated by study related activities.
Participates are requested to read an information letter, sign an informed
consent and complete a baseline measurement. Patients start with E-Exercise
after compliance with these study activities.
In the first week of the program the physical therapist will provide
information about OA and the principles of E-Exercise. Together with the
physical therapist, the patient chooses a central activity (e.g. walking,
cycling or swimming) and four strength/mobility exercises (videos) which are
presented on a website. To determine the physical load ability of the
participants, patients are instructed to perform a 3-day baseline test
(execution of selected activity) and 4 exercises in their home environment.
Results from the baseline test (time, intensity and pain scores) will be
entered on the website. Based on the performance from the baseline self-test,
a range of goals will automatically be generated and presented on the website.
The therapist gives instructions about the selected exercises.
In week 2, the performance of the 3-day self-test will be discussed. The
results from this test have been entered into an online form on the website.
Subsequently, the participant chooses, in consultation with their physical
therapist, one of the proposed goals on the website. Depending on the selected
goal, 12 tailored modules are generated and presented weekly on the website.
The personal goal and upcoming online modules will be discussed and the four
strength/mobility exercises will be again instructed by the physical therapist.
The patients are encouraged the execute the first online module.
From week 3 to week 5, patients are instructed to perform three online modules.
In week 6, a third face-to-face treatment will take place. During this session
patients* progress will be evaluated with respect to the online modules, the
evaluation of the exercise will take place and the upcoming modules will be
discussed. If necessary, the therapist can decide to schedule an additional
face-to-face treatment between week 7-12. This optional session is indicated
for patients who are less capable to perform unsupervised physical exercises.
Indications for this additional session are made by the physical therapist
themselves.
From week 7 to week 12, patients are instructed to perform another seven online
modules. In week 13, the final face-to-face treatments will take place. In this
final treatment the physical therapist will support and reinforce patients to
maintain their active lifestyle.
Study burden and risks
Since the study has low demands on the participants and selection criteria are
used to exclude participants with a contra-indication for physical activity,
the risks for participation are low.
Laan van Nieuw Oost-Indië 334
Den Haag 2593 CE
NL
Laan van Nieuw Oost-Indië 334
Den Haag 2593 CE
NL
Listed location countries
Age
Inclusion criteria
Patient inclusion criteria:
1) Osteoarthritis of the knee and/or hip according to the clinical criteria of the American College of Rheumatology. For knee OA: (i.e. (Altman et al, 1986).Diagnosis knee OA: knee pain and at least three of the following six: age > 50 years, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth.Diagnosis hip OA: Hip pain and hip internal rotation < 15 degree and hip flexion * 115 degree. Or hip internal rotation * 15 degree and pain on hip internal rotation and morning stiffness of the hip * 60 minutes and age > 50 years
2) Not meeting the recommendations of the Dutch Norm for Health-enhancing Physical Activity (Thirty minutes or more of at least moderate-intensity aerobic physical activity on at least five days each week)
3) age between 40 and 80 years
4) No participation in exercise therapy and/or physical activity program in the in the last 6 months
Exclusion criteria
Exclusion criteria patients:
1) Being on a waiting list for a knee or hip replacement surgery
2) Contra-indication for physical activity without supervision (such as cardiovascular diseases)
3) No access to internet
4) Inability to understand the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL46358.008.13 |