Patient AdherencePAPANCT02996955
Patient Adherence to a Physical Activity Advice
A study testing social support, treatment of illness perceptions and Activ8 in people with Patient Adherence, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Adherence
- What is being tested?
- social support, treatment of illness perceptions and Activ8
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-specific low back pain
Who cannot join
- Patients physical active in accordance with the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007)
- Patients with specific low back pain
- Onset of the low back pain after age 50 years,
- Continuous pain regardless of posture or movement,
- Nocturnal pain,
- General malaise,
Show all 15Show fewer
- History of malignancy,
- Unexplained weight loss,
- Elevated erythrocyte sedimentation rate (ESR)
- Previous vertebral fracture,
- Older person with hip fracture,
- Prolonged use of corticosteroids,
- Onset of low back pain before age 20 years,
- Iridocyclitis,
- History of unexplained peripheral arthritis or inflammatory bowel disease,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice
Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Advising regular physical activity is the mainstay in physical therapy treatment. This includes an appeal to patients to adhere to an activity advice. Patient adherence to an activity advice is poor. In this study an intervention consisting of treatment of illness perceptions with or without organizing social support to increase adherence to an activity advice will be investigated.
The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence .
Read more
This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years presenting with at least a second episode of non-specific low back pain.
Patients in the intervention and control group will be asked to perform a physical activity advice. During two physiotherapy treatment sessions treatment of illness perceptions is performed in both groups. In the intervention group organizing social support by a partner or friend is added.
Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the intervention group is clinically relevant.
During four appointments several questionnaires have to be filled in and during two physiotherapy treatment sessions half an hour treatment of illness perceptions will be performed. Social support by a partner or friend will be organized during the same physiotherapy treatment sessions in the intervention group. During three separate weeks patients have to wear an activity monitor. Patients will be treated according to the Dutch Low Back Pain guideline; no adverse effects will be expected.
Read the detailed description
Objective of the study:
The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, 2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence to an activity advice.
Study design:
This study is a multicentre randomized two arm, controlled clinical trial. During a twelve-week intervention period, one group of patients will receive an activity advice added to usual treatment including 'treatment of illness perceptions' (C-group). The other group will receive an activity advice and the intervention addressing social support by a partner or friend added to usual treatment including 'treatment of illness perceptions' (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks. Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12 centres for physiotherapy in the province Zuid-Holland, the Netherlands.
Study population:
It is mentioned that individuals with recurrent non-specific low back pain score more unfavourable on lifestyle risk factors including physical inactivity than individuals without or first time non-specific low back pain (van Oostrom et al., 2012). To include potential physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with at least a second episode of non-specific low back pain who are not physical active in accordance with the NNGB are recruited for the study.
Intervention (if applicable):
In both the C- and SoSup-group an activity advice will be added to usual treatment. The advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive treatment on illness perceptions according to the common sense model to the patient in the presence of the partner or friend will be given. During a maximum of two half-hour contacts in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line, causes, controllability, and curability of low back pain are mapped, maladaptive perceptions are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The intervention in the SoSup-group (intervention group), organizing social support by a partner or friend depending on patient's preferences, will be added. During a maximum of two half-hour contacts (one for explanation and one for evaluation), in a standardised discussion the partner or friend will be stimulated to support the patient in executing the activity advice. During 12 weeks the social support by a partner or friend will be executed for at least 5 times a week.
Primary study parameters/outcome of the study:
The primary outcome measure will be walking and/or cycling according to the NNGB and social support.
Secundary study parameters/outcome of the study (if applicable):
Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI, number of recurrences of non-specific low back pain, measures of attitude and intention to physical activity 3. measures of refusal of the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
The social support described in this study is designed for better outcomes of physical activity levels patients suffering low back pain, and has no proven advantage on better outcomes on pain and disability in non-specific low back pain sufferers. Therefore we consider there is no disadvantage in the SoSup-group versus the C-group because patients in both groups receive concomitant best evidence healthcare according to the Dutch guideline for low back pain (Staal et al., 2013). No adverse effects of the interventions are expected. There are no ethical implications to be expected as a result of this study, treatment of all patients during the intervention period will be according to the Dutch guideline for low back pain.
- Conditions
- Patient Adherence
- Being tested
- social support, treatment of illness perceptions, Activ8, activity advice
- Keywords
- Low Back Pain, Social Support, Illness Perceptions, Activity Advice
- Medical subject headings
- Patient Compliance, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social supportBehavioural
behaviour change intervention
treatment of illness perceptionsBehavioural
educational interview
Activ8Device
wearing a move monitor
activity adviceOther
walking or cycling 5 days a week during at least half an hour
| Study group | Role | What they receive |
|---|---|---|
| SoSup group | Experimental | usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8 Receives: Behavioral: social support; Behavioral: treatment of illness perceptions; Device: Activ8; Other: activity advice |
| C group | Active comparator | usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8 Receives: Behavioral: treatment of illness perceptions; Device: Activ8; Other: activity advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to the activity advice
proportion of patients (non)adhering to the activity advice measured by the Activ8
Measured: 12 weeks
Secondary outcomes (1)
changes in patient's illness perceptions
proportion of patients with (un)changed illness perceptions measured by the Brief Illness Perception Questionnaire- short, Dutch version.
Measured: base line, one week, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob de Bie, Prof. PhD, Study chair, Maastricht UniversityHenk v Mameren, Em Prof PhD, Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996955
- Sponsor's protocol ID
- NL58005.096.16
- Acronym
- PAPA
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2016
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van Koppen B, Zandwijk P, van Mameren H, de Bie R. Patient adherence to physical activity advice (PAPA) in patients with low back pain: Study protocol for a multicentre randomized controlled trial. Physiother Res Int. 2022 Oct;27(4):e1969. doi: 10.1002/pri.1969. Epub 2022 Aug 17.
PubMed 35975659
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice
- ClinicalTrials.gov ID
- NCT02996955
- Acronym / sponsor ID
- PAPA / NL58005.096.16
- Conditions
- Patient Adherence
- Keywords
- Low Back Pain, Social Support, Illness Perceptions, Activity Advice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Advising regular physical activity is the mainstay in physical therapy treatment. This includes an appeal to patients to adhere to an activity advice. Patient adherence to an activity advice is poor. In this study an intervention consisting of treatment of illness perceptions with or without organizing social support to increase adherence to an activity advice will be investigated.
The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence .
This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years presenting with at least a second episode of non-specific low back pain.
Patients in the intervention and control group will be asked to perform a physical activity advice. During two physiotherapy treatment sessions treatment of illness perceptions is performed in both groups. In the intervention group organizing social support by a partner or friend is added.
Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the intervention group is clinically relevant.
During four appointments several questionnaires have to be filled in and during two physiotherapy treatment sessions half an hour treatment of illness perceptions will be performed. Social support by a partner or friend will be organized during the same physiotherapy treatment sessions in the intervention group. During three separate weeks patients have to wear an activity monitor. Patients will be treated according to the Dutch Low Back Pain guideline; no adverse effects will be expected.
Detailed description
Objective of the study:
The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, 2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence to an activity advice.
Study design:
This study is a multicentre randomized two arm, controlled clinical trial. During a twelve-week intervention period, one group of patients will receive an activity advice added to usual treatment including 'treatment of illness perceptions' (C-group). The other group will receive an activity advice and the intervention addressing social support by a partner or friend added to usual treatment including 'treatment of illness perceptions' (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks. Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12 centres for physiotherapy in the province Zuid-Holland, the Netherlands.
Study population:
It is mentioned that individuals with recurrent non-specific low back pain score more unfavourable on lifestyle risk factors including physical inactivity than individuals without or first time non-specific low back pain (van Oostrom et al., 2012). To include potential physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with at least a second episode of non-specific low back pain who are not physical active in accordance with the NNGB are recruited for the study.
Intervention (if applicable):
In both the C- and SoSup-group an activity advice will be added to usual treatment. The advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive treatment on illness perceptions according to the common sense model to the patient in the presence of the partner or friend will be given. During a maximum of two half-hour contacts in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line, causes, controllability, and curability of low back pain are mapped, maladaptive perceptions are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The intervention in the SoSup-group (intervention group), organizing social support by a partner or friend depending on patient's preferences, will be added. During a maximum of two half-hour contacts (one for explanation and one for evaluation), in a standardised discussion the partner or friend will be stimulated to support the patient in executing the activity advice. During 12 weeks the social support by a partner or friend will be executed for at least 5 times a week.
Primary study parameters/outcome of the study:
The primary outcome measure will be walking and/or cycling according to the NNGB and social support.
Secundary study parameters/outcome of the study (if applicable):
Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI, number of recurrences of non-specific low back pain, measures of attitude and intention to physical activity 3. measures of refusal of the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
The social support described in this study is designed for better outcomes of physical activity levels patients suffering low back pain, and has no proven advantage on better outcomes on pain and disability in non-specific low back pain sufferers. Therefore we consider there is no disadvantage in the SoSup-group versus the C-group because patients in both groups receive concomitant best evidence healthcare according to the Dutch guideline for low back pain (Staal et al., 2013). No adverse effects of the interventions are expected. There are no ethical implications to be expected as a result of this study, treatment of all patients during the intervention period will be according to the Dutch guideline for low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoSup group | Experimental | Behavioral: social support, Behavioral: treatment of illness perceptions, Device: Activ8, Other: activity adviceusual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8 |
| C group | Active comparator | Behavioral: treatment of illness perceptions, Device: Activ8, Other: activity adviceusual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-specific low back pain
Key exclusion criteria (15 listed)
- Patients physical active in accordance with the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007)
- Patients with specific low back pain
- Onset of the low back pain after age 50 years,
- Continuous pain regardless of posture or movement,
- Nocturnal pain,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| social supportbehaviour change intervention | Behavioural | SoSup group |
| treatment of illness perceptionseducational interview | Behavioural | C group, SoSup group |
| Activ8wearing a move monitor | Device | C group, SoSup group |
| activity advicewalking or cycling 5 days a week during at least half an hour | Other | C group, SoSup group |
Primary outcome
adherence to the activity advice
Time frame: 12 weeks
proportion of patients (non)adhering to the activity advice measured by the Activ8
1 secondary outcome
changes in patient's illness perceptions
Time frame: base line, one week, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 35975659van Koppen B, Zandwijk P, van Mameren H, de Bie R. Patient adherence to physical activity advice (PAPA) in patients with low back pain: Study protocol for a multicentre randomized controlled trial. Physiother Res Int. 2022 Oct;27(4):e1969. doi: 10.1002/pri.1969. Epub 2022 Aug 17.
- Individual participant dataSharing planned: No
Related trials for Patient Adherence
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
RecruitingObservational study
Patient Satisfaction Following Multidisciplinary Cancer Care Assessment in Day Hospital.
Patient Satisfaction, Cancer
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob de Bie, Prof. PhD study chair
Maastricht University
Henk v Mameren, Em Prof PhD study chair
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social support, treatment of illness perceptions and Activ8 in people with Patient Adherence, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to the activity advice (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.