Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions
Phase: NA
Conditions: Rehabilitation
Sponsor: Vastra Gotaland Region

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
Version Consort:1 
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Summary 
Background 
Health literacy and sense of coherence affects patient participation in health care decisions, 
adherence to medical advice and health outcome. 
 
Objectives  
Assess effect of interactive patient education versus treatment as usual (TAU) on patient work 
ability and perceived health in a primary care setting. Estimate incremental cost effectiveness 
(ICER) of intervention. 
 
Design and methods 
A cluster randomized controlled trial comparing intervention with TAU. Inclusion on intention to 
treat. Randomization at primary care center (PCC) level. Computer generated tables to allocate 
study arm, ratio 1:1. Investigator blinded to allocation during PCC recruitment. Included PCCs 
blinded to allocation during selection. Follow-up with validated questionnaires at baseline, 3, 6, 
and 12 months distributed digitally. Standard statistical methods used for descriptive statistics. 
Means of intraindividual activity level, and quality of life (QoL) compared using mixed model 
analysis with repeated measures.  
 
Participants and power 
Eligibility criteria: aged 18-64 years, health-related impaired work ability since > 60 net days last 6 
months and rehabilitation barriers. Statistic power of 80% to identify a difference of 20 net 
inactive days and P < 0.05 with 400 patients from 30-40 PCCs in Region Västra Götaland, 
Sweden. 
 
Intervention 
Supervised study groups meeting half day a week for 8 consecutive weeks. Interactive patient 
education aiming to optimize participant health literacy and sense of coherence. 
 
Main outcome measures 
Net days with scheduled activity  
 
Expected findings 
Positive difference in net days with scheduled activity in intervention group. 
 
Funding 
Familjen Kamprads stiftelse   
 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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Introduction 
 
Working is good for self-esteem and social relationships1 and most individuals want to participate 
in both social and occupational activities.2 Long-term disability entails emotional challenges 
related to loss of work and family roles3 and the same medical diagnosis will have different 
consequences for different individuals.2,4 Sickness absence is associated with loss of control of 
private and working life5 and psychiatric-somatic comorbidity is common among long-term sick 
leavers experiencing difficulty resuming work.6,7,8 
 
Sense of coherence (SOC) describes life in terms of being understandable, manageable and 
meaningful. SOC depends on individual factors and life circumstances. High SOC strengthens the 
individual and protects against malaise due to external stress whereas individuals with low SOC 
tend to look at themselves as victims, which has a negative effect on problem solving.9 
 
Health literacy (HL) includes skills needed to be involved in health care decisions including 
problem solving and communication.10 These abilities are influenced by education and 
socioeconomic factors contributing to an inequitable health.11 Health literacy decreases with 
mental illness and stress.10 
 
In rehabilitation, it is important to recognise individual needs and set goals that are meaningful to 
the person.2,3 Inviting patients to actively take part in finding solutions to their problems is 
therapeutical12 and will affect adherence to medical advice as well as health outcome and patient 
satisfaction.13,14 Peer support2,3 and improved social function may contribute to the ability to work 
despite chronic illness.15 Uncertainty, both related to finance, own capabilities, and planning the 
future are known barriers to rehabilitation.16,17,18 
 
Social cost for sickness absence in Sweden is huge19 and knowledge about what interventions 
will promote return to work is insufficient.20 A pilot study (in manuscript) of an intervention with 
interactive patient education aiming to increase sense of coherence and health literacy has shown 
promising results. The study with 20 patients showed reduced need for sick leave as well as 
statistically significant increase in health literacy, sense of meaningfulness (subscale for SOC), 
and social function (subscale for health-related quality of life) compared to baseline after six 
months (the time frame of the study). The pilot did not include a control group and the study was 
too small to detect change on all sub scales, but the trend was positive or neutral for all sub 
scales. A randomized controlled study is needed to further investigate the intervention. 
 
Aim 
 
To study the effect of interactive patient education versus treatment as usual (TAU) on patient net 
days with scheduled activity in a primary care setting including patients aged 18-64 with health-
related impaired work ability since > 60 net days over the last six months. Estimate incremental 
cost effectiveness (ICER) of intervention. 
 
Research questions 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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1. What is the effect of interactive patient education in supervised study groups on net days with 
scheduled activity in patients of working age with long-term health-related work impairment 
(measured as change in net days with work / scheduled work preparatory rehabilitation 
(unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) 
from baseline to 6 months after baseline). Primary research question. 
 
2. What is the effect of interactive patient education in supervised study groups on net days with 
scheduled activity in patients of working age with long-term health-related work impairment 
(measured as change in net days with work / scheduled work preparatory rehabilitation 
(unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) 
from baseline to 3 months after baseline).  
 
3. What is the effect of interactive patient education in supervised study groups on net days with 
scheduled activity in patients of working age with long-term health-related work impairment 
(measured as change in net days with work / scheduled work preparatory rehabilitation 
(unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) 
from baseline to 12 months after baseline).  
 
4. What is the effect of interactive patient education in supervised study groups on participants' 
health-related quality of life (measured by change in scores in EQ-5D21 from baseline to 3 
months after baseline).  
  
5. What is the effect of interactive patient education in supervised study groups on participants' 
health-related quality of life (measured by change in scores in EQ-5D21 from baseline to 6 
months after baseline).  
  
6. What is the effect of interactive patient education in supervised study groups on participants' 
health-related quality of life (measured by change in scores in EQ-5D21 from baseline to 12 
months after baseline). 
  
7. What is the effect of interactive patient education in supervised study groups on the 
participants' sense of coherence (measured by changes in scores in SOC-13 scale in 
Swedish9 from baseline to 3 months after baseline). 
 
8. What is the effect of interactive patient education in supervised study groups on the 
participants' sense of coherence (measured by changes in scores in SOC-13 scale in 
Swedish9 from baseline to 6 months after baseline). 
 
9. What is the effect of interactive patient education in supervised study groups on the 
participants' sense of coherence (measured by changes in scores in SOC-13 scale in 
Swedish9  from baseline to 12 months after baseline). 
 
10. What is the effect of interactive patient education in supervised study groups on participants' 
health literacy (measured by change in scores in HLS-EU-Q16-SE22 from baseline to 3 months 
after baseline). 
 
11. What is the effect of interactive patient education in supervised study groups on participants' 
health literacy (measured by change in scores in HLS-EU-Q16-SE22 from baseline to 6 months 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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after baseline). 
 
12. What is the effect of interactive patient education in supervised study groups on participants' 
health literacy (measured by change in scores in HLS-EU-Q16-SE22 from baseline to 12 
months after baseline). 
 
13. What is the effect of interactive patient education in supervised study groups on participants' 
general self-efficacy (measured as change in scores in S-GSE23 from baseline to 3 months 
after baseline). 
 
14. What is the effect of interactive patient education in supervised study groups on participants' 
general self-efficacy (measured as change in scores in S-GSE23 from baseline to 6 months 
after baseline). 
 
15. What is the effect of interactive patient education in supervised study groups on participants' 
general self-efficacy (measured as change in scores in S-GSE23 from baseline to 12 months 
after baseline). 
 
16. What is the effect of interactive patient education in supervised study groups on praticipants’ 
social function (measured as change in scores in the two questions used in the sub scale 
”Social function” of RAND-3624 from baseline to 3 months after baseline). 
 
17. What is the effect of interactive patient education in supervised study groups on praticipants’ 
social function (measured as change in scores in the two questions used in the sub scale 
”Social function” of RAND-3624 from baseline to 6 months after baseline). 
 
18. What is the effect of interactive patient education in supervised study groups on praticipants’ 
social function (measured as change in scores in the two questions used in the sub scale 
”Social function” of RAND-3624 from baseline to 12 months after baseline). 
 
19. What is the effect of interactive patient education in supervised study groups on participants' 
work ability (measured as change in scores in WAI25 from baseline to 3 months after baseline). 
 
20. What is the effect of interactive patient education in supervised study groups on participants' 
work ability (measured as change in scores in WAI25 from baseline to 6 months after baseline). 
 
21. What is the effect of interactive patient education in supervised study groups on participants' 
work ability (measured as change in scores in WAI25 from baseline to 12 months after 
baseline). 
 
22. What is the effect of interactive patient education in supervised study groups on participants’ 
job content (measured as change in score in Karasek Job Content Questionnaire26 from 
baseline to 3 months after baseline). 
 
23. What is the effect of interactive patient education in supervised study groups on participants’ 
job content (measured as change in score in Karasek Job Content Questionnaire26 from 
baseline to 6 months after baseline). 
 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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24. What is the effect of interactive patient education in supervised study groups on participants’ 
job content (measured as change in score in Karasek Job Content Questionnaire26 from 
baseline to 12 months after baseline). 
 
25. What is the effect of interactive patient education in supervised study groups on the total 
number of net and gross sick leave days during the follow-up period (measured as change in 
measures defined by the Swedish Social Insurance Agency27 from baseline to 3 months after 
baseline). 
 
26. What is the effect of interactive patient education in supervised study groups on the total 
number of net and gross sick leave days during the follow-up period (measured as change in 
measures defined by the Swedish Social Insurance Agency27 from baseline to 6 months after 
baseline). 
 
27. What is the effect of interactive patient education in supervised study groups on the total 
number of net and gross sick leave days during the follow-up period (measured as change in 
measures defined by the Swedish Social Insurance Agency27 in from baseline to 12 months 
after baseline). 
 
28. What is the effect of interactive patient education in supervised study groups on participants' 
level of physical activity (measured as change in time spent on physical activities during 
leisure time according to LTPAI28 from baseline to 3 months after baseline). 
 
29. What is the effect of interactive patient education in supervised study groups on participants' 
level of physical activity (measured as change in time spent on physical activities during 
leisure time according to LTPAI28 from baseline to 6 months after baseline). 
 
30. What is the effect of interactive patient education in supervised study groups on participants' 
level of physical activity (measured as change in time spent on physical activities during 
leisure time according to LTPAI28 from baseline to 12 months after baseline). 
 
31. What is the effect of interactive patient education in supervised study groups on participants’ 
Body Mass Index, BMI (measured as change in BMI from baseline to 3 months after baseline). 
 
32. What is the effect of interactive patient education in supervised study groups on participants’ 
Body Mass Index, BMI (measured as change in BMI from baseline to 6 months after baseline). 
 
33. What is the effect of interactive patient education in supervised study groups on participants’ 
Body Mass Index, BMI (measured as change in BMI from baseline to 12 months after 
baseline). 
 
34. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of depression (measured as change in score in MADRS-S29 from baseline to 3 
months after baseline). 
 
35. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of depression (measured as change in score in MADRS-S29 from baseline to 6 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
Version Consort:1 
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months after baseline). 
 
36. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of depression (measured as change in score in MADRS-S29 from baseline to 12 
months after baseline). 
 
37. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of anxiety (measured change in score in GAD-730 from baseline to 3 months after 
baseline). 
 
38. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of anxiety (measured change in score in GAD-730 from baseline to 6 months after 
baseline). 
 
39. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of anxiety (measured change in score in GAD-730 from baseline to 12 months after 
baseline).  
 
 
 
40. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of exhaustion (measured as change in score in KEDS31 from baseline to 3 months 
after baseline). 
 
41. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of exhaustion (measured as change in score in KEDS31 from baseline to 6 months 
after baseline). 
 
42. What is the effect of interactive patient education in supervised study groups on participants’ 
symptoms of exhaustion (measured as change in score in KEDS31 from baseline to 12 months 
after baseline). 
 
43. What is the effect of interactive patient education in supervised study groups on participant 
pain catastrophizing (measured as change in score in PCS32 from baseline to 3 months after 
baseline). 
 
44. What is the effect of interactive patient education in supervised study groups on participant 
pain catastrophizing (measured as change in score in PCS32 from baseline to 6 months after 
baseline). 
 
45. What is the effect of interactive patient education in supervised study groups on participant 
pain catastrophizing (measured as change in score in PCS32 from baseline to 12 months after 
baseline). 
 
46. What is the effect of interactive patient education in supervised study groups on participant 
pain (measured as change in score in ÖMPSQ33 from baseline to 3 months after baseline). 
 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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47. What is the effect of interactive patient education in supervised study groups on participant 
pain (measured as change in score in ÖMPSQ33 from baseline to 6 months after baseline). 
 
48. What is the effect of interactive patient education in supervised study groups on participant 
pain (measured as change in score in ÖMPSQ33 from baseline to 12 months after baseline). 
 
49. What is the effect of interactive patient education in supervised study groups on participant 
pain spreading (measured as change in number of painful body regions35 from baseline to 3 
months after baseline). 
 
50. What is the effect of interactive patient education in supervised study groups on participant 
pain spreading (measured as change in number of painful body regions35 from baseline to 6 
months after baseline). 
 
51. What is the effect of interactive patient education in supervised study groups on participant 
pain spreading (measured as change in number of painful body regions35 from baseline to 12 
months after baseline). 
52. What is the effect of interactive patient education in supervised study groups on participant 
trust in own know-how and ability related to improving health (measured as change in score in 
questions about trust in own know-how and ability to improving health from baseline to 3 
months after baseline).  
53. What is the effect of interactive patient education in supervised study groups on participant 
trust in own know-how and ability related to improving health (measured as change in score in 
questions about trust in own know-how and ability to improving health from baseline to 6 
months after baseline).  
54. What is the effect of interactive patient education in supervised study groups on participant 
trust in own know-how and ability related to improving health (measured as change in score in 
questions about trust in own know-how and ability to improving health from baseline to 12 
months after baseline).  
55. What is the effect of interactive patient education in supervised study groups on participants 
being informed as patients and being a partners in health care (measured as change in score 
in questions about informed as a patient and being a partner in health care from baseline to 3 
months after baseline).  
56. What is the effect of interactive patient education in supervised study groups on participants 
being informed as patients and being a partners in health care (measured as change in score 
in questions about informed as a patient and being a partner in health care from baseline to 6 
months after baseline).  
57. What is the effect of interactive patient education in supervised study groups on participants 
being informed as patients and being a partners in health care (measured as change in score 
in questions about informed as a patient and being a partner in health care from baseline to 12 
months after baseline). 
58. What is the effect of interactive patient education in supervised study groups on participant 
visits to primary health care (research subjects are asked at baseline if they had to visit the 
primary health care center during the preceding two months. The same question is asked at 3 
months. The measurement is the change in proportion of research subjects who visited the 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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primary health care center). 
 
59. What is the effect of interactive patient education in supervised study groups on participant 
visits to primary health care (research subjects are asked at baseline if they had to visit the 
primary health care center during the preceding two months. The same question is asked at 6 
months. The measurement is the change in proportion of research subjects who visited the 
primary health care center). 
 
60. What is the effect of interactive patient education in supervised study groups on participant 
visits to primary health care (research subjects are asked at baseline if they had to visit the 
primary health care center during the preceding two months. The same question is asked at 
12 months. The measurement is the change in proportion of research subjects who visited the 
primary health care center). 
 
Methods 
The study uses a quantitative research method common in clinical studies: a pragmatic cluster 
randomized controlled trial20 with two groups (intervention and control). The study will be 
registered in Clinicaltrials.gov with detailed study protocol. Data will be reported according to the 
CONSORT checklist and flow charts for cluster randomized clinical trials.34 
Selection of patients 
The study is designed as a pragmatic cluster randomized controlled trial with two groups 
(intervention and control). 
Inclusion criteria 
• 
Patients of all sexes attending primary care centers included in the study 
• 
Aged 18-64 years 
• 
Health-related impaired work ability > 60 net days last six months  
 
Exclusion criteria 
• 
Acute crisis 
• 
Serious mental disorder needing psychiatric specialist care 
• 
Serious somatic disease a definite barrier to rehabilitation for a foreseeable future 
• 
Cognitive impairment or not speaking / understanding Swedish 
Group allocation 
Patients will be included on intention to treat. Randomization will be performed at primary care 
center (PCC) level by a statistician who will use computer generated tables to allocate study arm 
in ratio 1:1. The randomization will be performed in 2-3 batches with 10-20 PCCs in each batch. 
Intervention group 
Interactive patient education in supervised study groups in addition to treatment as usual 
according to local routines. 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
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The intervention consists of interactive patient education in supervised study groups with 6-12 
participants meeting half a day a week for 8 consecutive weeks following a defined study plan. 
The study plan was developed by primary care professionals based on existing research about 
SOC and health literacy but will be delivered in cooperation with adult educational institutes. The 
supervisors will have previous coaching experience but no medical profession. Peer support as 
well as practicing social and communicative skills is part of the intervention. The participants will 
be engaged in group discussions as well as practical work with personal goals and action plans. 
Unlike current interventions in primary care, this intervention does not focus on medical needs nor 
psychotherapy (although it goes in line with both general recommendations about health habits 
and acceptance and commitment theory), instead it focuses on problem solving strategies and 
communication, on basic understanding of our welfare system, and practical understanding of 
where to find help when needed. 
Control group 
Treatment as usual according to local routines. 
Data collection 
Data collection with validated questionnaires as well as demographic data at baseline and after 6 
and 12 months. The research subjects will answer all questions and questionnaires in a web 
based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, 
iPad or computer. Individual web links to the questionnaires will be distributed via e-mail.  
The following data will be collected only at baseline: 
• 
Demographic data: age, sex, country of origin. 
The following data will be collected at baseline and at follow-up after 6 and 12 months: 
• 
Demographic data: family situation, education, smoking, alchohol consumption, substance 
use (all multi choice) 
• 
Health-related quality of life: measured with EQ-5D21. Five questions with response 
alternatives on a 3-grade scale. The responses are weighed and presented as a score 
between 0 (dead) and 1 (optimal health). Also measured with a VAS-scale where 0 is worst 
possible health ant 100 is optimal health. 
 
 
 
• 
Health literacy: measured with HLS-EU-Q16-SE22. Sixteen questions with response 
alternatives on a 4-grade scale. An overall HLS-EU-Q16 index (CHL) may be calculated and 
divided into three categories: sufficient CHL 13–16 score points, problematic CHL 9–12 score 
points or inadequate CHL 0–8 score points.  
• 
General self-efficacy: measured with S-GSE23. Seven questions with response alternatives on 
a 4-grade scale. Score range 7-28. Higher value indicates higher self-efficacy. 
• 
Social function: health related social function measured with items 20 and 32 of RAND-3624 
i.e. the sub scale ”Social function”. Each of the two items has 5 response choices valued 0, 
25, 50, 75 and 100. A high score indicates lesser health-related limitation on social 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
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functioning. The two items are be averaged together to represent the current health-related 
social function as a percentage of full function. 
• 
Leisure time physical activity: measured with LTPAI28. This instrument measures time spent in 
physical activities during leisure time. 
• 
Body Mass Index (BMI): calculated from height and weight  
• 
Medications: research subjects are asked for a list of current medications. 
• 
Primary health care center visits: number of visits to primary health care centers during the 
preceding two months. 
• 
Current employment: profession (free text) and working hours (multi choice).  
• 
Sick leave: history of sick leave (multi choice - duration), current sick leave (multi choice - 
duration), degree of sick leave (multi choice - percentage of ordinary working hours) 
• 
Participation in scheduled rehabilitation: participation in medical rehabilitation and/or work 
preparatory rehabilitation (multi choice - type of activity), number of hours per week (free text), 
whether rehabilitation is planned but not initiated (multi choice - type of planned activity) 
• 
Job content: measured with the Karasek Job Content Questionnaire.26 Seventeen questions 
about job strain and job control. Each item with response alternatives on a 4-grade scale.  
• 
Work ability: perceived work ability measured with WAI25. WAI is a VAS-scale with response 
alternatives on a 10-grade scale, higher number indicates higher work ability. 
• 
Patient perception of time left before being able to return to work (multi choice - time frame) 
• 
Questions about trust in own know-how and ability related to improving health: seventeen 
questions with response alternatives on a 5-grade scale.  
• 
Questions about being informed as a patient and being a partner in health care: five questions 
with response alternatives on a 5-grade scale. 
• 
Sence of coherence: measured with SOC-139. Thirteen questions with response alternatives 
on a 7-grade scale. Score range 7-91. Higher value indicates higher sense of coherence. 
• 
Pain: presence of pain (multiple choice). 
• 
Pain: quantified pain measured with ÖMPSQ33  
• 
Spreading of pain: measured with pain drawing with 18 predefined body regions35 
• 
Pain catastrophizing: measured with the PCS scale32. Thirteen questions with response 
alternatives on a 5-grade scale. Score range 0-52. Higher value indicates increased pain 
catastrophizing. 
• 
Symptoms of depression: measured with MADRS-S29. Nine questions with response 
alternatives on a 6-grade scale. Score range 0-54. Higher value indicates more symptoms of 
depression. Since MADRS-S contains a question indicating suicide risk (question number 9) a 
notification will be sent to the research assistent whenever research subjects’ answer >4. The 
research assistant, in charge of the CodeKey, will notify the general practitioner in charge at 
their PCC. If the suicide risk is acute the research subject will be excluded from the study. 

                                           
 
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• 
Symptoms of anxiety: measured with GAD-7 scale30. Seven questions with response 
alternatives on a 4-grade scale. Score range 0-21. Higher value indicates more symptoms of 
anxiety. An extra question about daily life consequences of anxiety - one question with 4 
response alternatives. 
• 
Symptoms of exhaustion: measured with KEDS31. Nine questions with response alternatives 
on a 6-grade scale. Score range 0-54. Higher value indicates more symptoms of exhaustion. 
• 
Data about sick leave will be collected from the Swedish Social Insurance Agency database 
MiDAS.  
Procedure 
The investigator will be blinded to allocation during PCC recruitment. The head of each PCC fills 
in written consent to participate in the study. A study start-up meeting will be held at each 
research PCC when an investigator will be informing the general practitioners and the 
rehabilitation coordinators at the PCC about the study. The investigator will be blinded to 
allocation when informing the PCCs.  
After the start-up meeting the included PCCs will compose a list of patients eligible for study 
inclusion. During the selection process the PCCs will be blinded to allocation. When the PCCs 
have completed their list of eligible patients they will be informed about allocation by the research 
assistant, and then they start asking their selected patients for consent to the research assistant 
contacting them with more information about the study.  
Names, phone numbers and addresses are collected for the patients who agree to more 
information. These patients will receive written information distributed by mail and the research 
assistant will be informing them about the study over the phone following a script based on the 
written patient information that has been approved by the ethical board. The research assistant 
will also have time to answer the patients´ questions. Patients agree to participate in the study by 
giving their written consent.  
Baseline is set to time for inclusion. PCCs and research subjects will be included in the study in 
”batches” for logistic reasons. There may only be 8-10 parallell intervention groups so only 16-20 
PCCs may start at the same time, half of which in control group. All research subjects from the 
same PCC will be included at the same.  
The research assistant will distribute individual links to the web based questionnaire at baseline 
and follow-up after 6 ant 12 months. 
Management of personal data 
Research subject identity is replaced with individual codes in esMaker. The research assistant will 
be in charge of the CodeKey and responsible for distributing the web links and for reminding the 
research subjects to fill in the questionnaires. Investigators will have access to the personal data 
but they will be blinded to the CodeKey and thus to research subject identities. Data will be 
stored in esMaker, which is approved for storing research data, linked to the primary 
investigator’s personal account on the Västra Götaland region password-protected network. 
Statistical analysis 
IBM SPSS version 20 or later will be used for statistical analysis. Data collected with esMaker may 
be exported directly into SPSS.  

                                           
 
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Questionnaires are summarized according to manuals. Standard statistical methods sill be used 
for descriptive statistics. Intraindividual change of study variables will be used to estimate the 
effect of the intervention on short term (6 months) and long term (12 months). Continuous 
variables will be analyzed by independent sample t-test or Mann-Whitney U test and categorical 
variables or frequencies by Pearson chi-square test. Means of intra-individual change of net 
inactivity days, quality of life, health literacy and sense of coherence scores will be compared 
between the intervention group and the TAU group by using mixed model analysis with repeated 
measures. These analyses will be adjusted for age, sex, education, and response variable at 
baseline. Statistical significance is set at p<0,05.  
Power analysis 
The study aims at statistic power of 80% to identify a difference of 20 net inactive days and P < 
0.05. This is possible if including 400 patients from 30-40 PCCs if there are about as many 
patients from each PCC. 
Assuming 15 health care centers (HCC) per treatment group, with an average of 12 patients per 
HCC (thus 180 subjects per treatment group) will have a power of at least 80 % and a significance 
of 5 %, using a two-sided test, to detect a difference 20 days of sick leave, with a variance of 32 
days and an intercluster correlation coefficient of 0. 3. The attrition rate is assumed to be 10%, 
hence we will want to include 13-14 patients on average in each HCC (hence, 200 patients per 
treatment group).  
Assuming 20 health care centers (HCC) per treatment group, with an average of 7 patients per 
HCC (thus 140 subjects per treatment group) will have a power of at least 80 % and a significance 
of 5 %, using a two-sided test, to detect a difference 20 days of sick leave, with a variance of 32 
days and an intercluster correlation coefficient of 0.3. The attrition rate is assumed to be 10%, 
hence we will want to include 8-10 patients on average in each HCC (hence, 200 patients per 
treatment group). 
Cost-effectiveness analysis 
A cost-effectiveness analysis is included in the study to estimate the intervention's incremental 
cost-effectiveness (ICER), ie the additional cost of the intervention translated into cost per quality-
adjusted life year (QALY). Change in health-related quality of life for the intervention, measured 
with the EQ-5D instrument, may be translated to QALYs using pre-calculated QALY weights for 
EQ-5D. The additional cost of the intervention is calculated comparing both direct and indirect 
costs (costs related to PCC visits, medication, treatment, rehabilitation efforts and lost work) 
between the intervention group and the control group.  
Expected results 
 
The expected finding is a positive difference in net days with scheduled activity in intervention 
group compared to control. Gain in perceived health-related quality of life translated to QALY 
weights is expected to stand in proportion to the incremental cost of the intervention. 
 
 

                                           
 
Study protocol: Effect of interactive patient education aiming to increase sense of coherence and health literacy 
on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
Version Consort:1 
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on work ability and health-related quality of life - LEARN-TO-COPE cluster randomized trial 
29th of Januari 2020   
Version Consort:1 
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