The project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk. The research programme is an ambitious and dedicated effort aiming at improvement of functioning and quality of life for individuals with persistent physical symptoms (PPS) and prevention of the development of chronic functional disorders and associated loss of working capacity and high use of health care. At present, access to specialized treatment of PPS is very limited and treatment capacity in general practice is restricted to brief consultations - often with poor opportunity to make a treatment plan for symptoms. As part of the research programme, the investigators have developed a web-based self-help programme for patient with PPS. This treatment programme is prescribed by the patient's general practitioner (GP). Only GPs who have participated in a short introduction course will be allowed for prescriptions. The investigators have applied a high degree of user involvement (GPs and patients) in the development process but there is a need to evaluate how the new treatment programme is in fact adopted by GPs and patients. With this study, the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs, patients and the health care system.
The project aims to evaluate the uptake and effects of the new self-help programme for PPS, the My Symptoms programme, prescribed and followed up by GPs. Specific objectives are to: 1. Describe the use of the programme during routine care. This includes 1. Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption) 2. A description of how often the follow-up consultation is completed according to the patients. 2. Explore patient characteristics (appropriateness) 3. Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity) 4. Evaluate effects on patients' health, quality of life, functioning and satisfaction with care 5. Estimate effects on patients' use of health care services 6. Estimate effects on patients' work productivity 7. Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.
Study Type
OBSERVATIONAL
Enrollment
120
My Symptoms supports patients' self-efficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. The patient is free to choose relevant tasks corresponding to wishes, needs/requirements and own perspectives. Summary of content: 1. Symptom explanations and facts about frequent symptoms including brief animated explanations 2. Physical energy (sleep, diet and activity) 3. Working with resources and strain in everyday life 4. Values and choices (meaning and existential issues) 5. Thoughts 6. Feelings (emotion regulation) 7. Self-care (attention incl. mindfulness and audio exercises) 8. Preparation for a follow-up visit with the GP and relapse prevention. The above modules connect to four general tools: symptom registration, 'don't break the chain', goal setting staircase and notebook. After 6 weeks: Voluntary GP follow-up consultation. After 8 weeks: End-of-treatment.
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGChange in symptom intensity
Symptom intensity measured by a numeric rating scale (0-10)
Time frame: Baseline to end of treatment (week 8)
Change in symptom interference
Symptom interference measured by a numeric rating scale (0-10)
Time frame: Baseline to end of treatment (week 8)
Change in symptom intensity
Symptom intensity measured by a numeric rating scale (0-10)
Time frame: Baseline to 3 months after end of treatment
Change in symptom interference
Symptom interference measured by a numeric rating scale (0-10)
Time frame: Baseline to 3 months after end of treatment
Change in symptom burden
Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)
Time frame: Baseline to end of treatment (week 8)
Change in symptom burden
Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)
Time frame: Baseline to 3 months after end of treatment
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Time frame: Baseline
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Time frame: End of treatment (week 8)
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Time frame: 3 months after end of treatment
Change in illness perception
Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.
Time frame: Baseline to end of treatment (week 8)
Change in illness perception
Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.
Time frame: Baseline to 3 months after end of treatment
Change in illness worry
The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.
Time frame: Baseline to end of treatment (week 8)
Change in illness worry
The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.
Time frame: Baseline to 3 months after end of treatment
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment.
Time frame: Baseline
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.
Time frame: End of treatment (week 8)
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.
Time frame: 3 months after end of treatment
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Time frame: Baseline
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Time frame: End of treatment (week 8)
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Time frame: 3 months after end of treatment
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Time frame: Baseline
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Time frame: End of treatment (week 8)
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Time frame: 3 months after end of treatment
Change of hope
One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.
Time frame: Baseline to end of treatment (week 8)
Change of hope
One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.
Time frame: Baseline to 3 months after end of treatment
Change in stress
Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.
Time frame: Baseline to end of treatment (week 8)
Change in stress
Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.
Time frame: Baseline to 3 months after end of treatment
Change in limiting behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.
Time frame: Baseline to end of treatment (week 8)
Change in limiting behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.
Time frame: Baseline to 3 months after end of treatment
Change in all or nothing behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.
Time frame: Baseline to end of treatment (week 8)
Change in all or nothing behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.
Time frame: Baseline to 3 months after end of treatment
Change in confidence in performing activities in the context of PPS
Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.
Time frame: Baseline to end of treatment (week 8)
Change in confidence in performing activities in the context of PPS
Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.
Time frame: Baseline to 3 months after end of treatment
Change in health-related quality of life
36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.
Time frame: Baseline to end of treatment (week 8)
Change in health-related quality of life
36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.
Time frame: Baseline to 3 months after end of treatment
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Time frame: Baseline
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Time frame: End of treatment (week 8)
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Time frame: 3 months after end of treatment
Credibility related to the eHealth programme
One item measuring credibility. A scale ranging from 'not meaningful at all' (1) to 'highly meaningful' (10) is provided.
Time frame: Baseline
Expectancy related to the eHealth programme
One item measuring expectancy. A scale ranging from 'not efficient at all' (1) to 'highly efficient' (10) is provided.
Time frame: Baseline
Evaluation of the referral consultation
Questionnaire comprising 6 items. The items are scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).
Time frame: Baseline
Evaluation of the eHealth programme
Questionnaire comprising 12 items. The items are scored on a five-point Likert-type scale representing the extent to which the patient find the programme easy to use or has experienced benefit. The scale ranges from 'not at all' (0) to 'to a very great extent' (4).
Time frame: End of treatment (week 8)
Recommendation of the eHealth programme
One item. The patient is asked to indicate whether he or she would recommend the treatment programme to a friend with similar problems. A VAS scale (0 ('not at all') - 10 ('highly recommend') is provided.
Time frame: End of treatment (week 8)
Evaluation of the follow up consultation
One item measuring satisfaction. The item is scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).
Time frame: End of treatment (week 8)
Self-rated global health change
Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).
Time frame: End of treatment (week 8)
Self-rated global health change
Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).
Time frame: 3 months after end of treatment
Adverse events
Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity
Time frame: End of treatment (week 8)
Adverse events
Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity
Time frame: 3 months after end of treatment
Quality-adjusted life year (QALY)
QALY is a single reported value based on the change in patient's health-related quality of life measured with the EuroQoL 5-domain 5-level (EQ-5D-5L) and valued using Danish QALY-weights.
Time frame: 6 months after end of treatment
Changes in health care use
Estimation of effects on patients' changes in use of health care services using Danish registers from a before-vs-after approach
Time frame: 6 months before baseline compared to 6 months after end of treatment
Changes in productivity costs
Changes in productivity costs i.e., the change in lost production due to changes in sick leaves and absence from work
Time frame: 6 months before baseline compared to 6 months after end of treatment
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