Persistent Physical Symptoms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMy Symptoms eHealth programme
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.
Sponsors
Aarhus University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 (target population for the programme) * The consultation targets symptom complaints * Listed with participating practice.
Exclusion criteria
* Symptoms are acute (not persistent) and there is no need for this intervention * Symptoms must primarily be treated by medicine or surgery * Patient severely affected by other disease * Not eligible due to language or cognitive problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom intensity | Baseline to end of treatment (week 8) | Symptom intensity measured by a numeric rating scale (0-10) |
| Change in symptom interference | Baseline to end of treatment (week 8) | Symptom interference measured by a numeric rating scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom burden | Baseline to end of treatment (week 8) | Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100) |
| Bodily Distress Syndrome | Baseline | Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1) |
| Change in illness perception | Baseline to end of treatment (week 8) | Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions. |
| Change in illness worry | Baseline to end of treatment (week 8) | The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry. |
| Anxiety | Baseline | Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment. |
| Depression | Baseline | Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression. |
| Distress | Baseline | Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress. |
| Change of hope | Baseline to end of treatment (week 8) | 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. |
| Change in stress | Baseline to end of treatment (week 8) | Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels. |
| Change in limiting behaviour | Baseline to end of treatment (week 8) | Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour. |
| Change in all or nothing behaviour | Baseline to end of treatment (week 8) | Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour. |
| Change in confidence in performing activities in the context of PPS | Baseline to end of treatment (week 8) | Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy. |
| Change in symptom intensity | Baseline to 3 months after end of treatment | Symptom intensity measured by a numeric rating scale (0-10) |
| Health-related quality of life | Baseline | 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. |
| Credibility related to the eHealth programme | Baseline | One item measuring credibility. A scale ranging from 'not meaningful at all' (1) to 'highly meaningful' (10) is provided. |
| Expectancy related to the eHealth programme | Baseline | One item measuring expectancy. A scale ranging from 'not efficient at all' (1) to 'highly efficient' (10) is provided. |
| Evaluation of the referral consultation | Baseline | Questionnaire comprising 6 items. The items are scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5). |
| Evaluation of the eHealth programme | End of treatment (week 8) | 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). |
| Recommendation of the eHealth programme | End of treatment (week 8) | 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. |
| Evaluation of the follow up consultation | End of treatment (week 8) | One item measuring satisfaction. The item is scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5). |
| Self-rated global health change | End of treatment (week 8) | 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). |
| Adverse events | End of treatment (week 8) | Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity |
| Quality-adjusted life year (QALY) | 6 months after end of treatment | 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. |
| Changes in health care use | 6 months before baseline compared to 6 months after end of treatment | Estimation of effects on patients' changes in use of health care services using Danish registers from a before-vs-after approach |
| Changes in productivity costs | 6 months before baseline compared to 6 months after end of treatment | Changes in productivity costs i.e., the change in lost production due to changes in sick leaves and absence from work |
| Change in health-related quality of life | Baseline to end of treatment (week 8) | 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. |
| Change in symptom interference | Baseline to 3 months after end of treatment | Symptom interference measured by a numeric rating scale (0-10) |
Countries
Denmark
Contacts
Primary ContactMarianne Rosendal, PhD
Backup ContactLisbeth Frostholm, PhD
Outcome results
None listed