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NCT Number: NCT06163014

My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care

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.

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Key information

Conditions

Persistent Physical Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Denmark

Location status: Recruiting

Location contact

Marianne Rosendal, MD, PhD

CONTACT

[email protected]

004520411619

About this study

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:

  • Describe the use of the programme during routine care. This includes
  • Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption)
  • A description of how often the follow-up consultation is completed according to the patients.
  • Explore patient characteristics (appropriateness)
  • Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity)
  • Evaluate effects on patients' health, quality of life, functioning and satisfaction with care
  • Estimate effects on patients' use of health care services
  • Estimate effects on patients' work productivity
  • Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Symptoms eHealth programme

Behavioral

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:

  • Symptom explanations and facts about frequent symptoms including brief animated explanations
  • Physical energy (sleep, diet and activity)
  • Working with resources and strain in everyday life
  • Values and choices (meaning and existential issues)
  • Thoughts
  • Feelings (emotion regulation)
  • Self-care (attention incl. mindfulness and audio exercises)
  • 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.

Primary outcomes

  1. Change in symptom intensity

    Time frame: Baseline to end of treatment (week 8)

    Symptom intensity measured by a numeric rating scale (0-10)

  2. Change in symptom interference

    Time frame: Baseline to end of treatment (week 8)

    Symptom interference measured by a numeric rating scale (0-10)

Secondary outcomes

  1. Change in symptom intensity

    Time frame: Baseline to 3 months after end of treatment

    Symptom intensity measured by a numeric rating scale (0-10)

  2. Change in symptom interference

    Time frame: Baseline to 3 months after end of treatment

    Symptom interference measured by a numeric rating scale (0-10)

  3. Change in symptom burden

    Time frame: Baseline to end of treatment (week 8)

    Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)

  4. Change in symptom burden

    Time frame: Baseline to 3 months after end of treatment

    Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)

  5. Bodily Distress Syndrome

    Time frame: Baseline

    Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)

  6. Bodily Distress Syndrome

    Time frame: End of treatment (week 8)

    Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)

  7. Bodily Distress Syndrome

    Time frame: 3 months after end of treatment

    Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)

  8. Change in illness perception

    Time frame: 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.

  9. Change in illness perception

    Time frame: Baseline to 3 months after end of treatment

    Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.

  10. Change in illness worry

    Time frame: 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.

  11. Change in illness worry

    Time frame: Baseline to 3 months after end of treatment

    The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.

  12. Anxiety

    Time frame: Baseline

    Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment.

  13. Anxiety

    Time frame: End of treatment (week 8)

    Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.

  14. Anxiety

    Time frame: 3 months after end of treatment

    Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.

  15. Depression

    Time frame: Baseline

    Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.

  16. Depression

    Time frame: End of treatment (week 8)

    Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.

  17. Depression

    Time frame: 3 months after end of treatment

    Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.

  18. Distress

    Time frame: Baseline

    Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.

  19. Distress

    Time frame: End of treatment (week 8)

    Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.

  20. Distress

    Time frame: 3 months after end of treatment

    Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.

  21. Change of hope

    Time frame: 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.

  22. Change of hope

    Time frame: Baseline to 3 months after end of treatment

    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.

  23. Change in stress

    Time frame: 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.

  24. Change in stress

    Time frame: Baseline to 3 months after end of treatment

    Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.

  25. Change in limiting behaviour

    Time frame: 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.

  26. Change in limiting behaviour

    Time frame: Baseline to 3 months after end of treatment

    Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.

  27. Change in all or nothing behaviour

    Time frame: 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.

  28. Change in all or nothing behaviour

    Time frame: Baseline to 3 months after end of treatment

    Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.

  29. Change in confidence in performing activities in the context of PPS

    Time frame: 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.

  30. Change in confidence in performing activities in the context of PPS

    Time frame: Baseline to 3 months after end of treatment

    Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.

  31. Change in health-related quality of life

    Time frame: 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.

  32. Change in health-related quality of life

    Time frame: Baseline to 3 months after end of treatment

    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.

  33. Health-related quality of life

    Time frame: 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.

  34. Health-related quality of life

    Time frame: End of treatment (week 8)

    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.

  35. Health-related quality of life

    Time frame: 3 months after end of treatment

    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.

  36. Credibility related to the eHealth programme

    Time frame: Baseline

    One item measuring credibility. A scale ranging from 'not meaningful at all' (1) to 'highly meaningful' (10) is provided.

  37. Expectancy related to the eHealth programme

    Time frame: Baseline

    One item measuring expectancy. A scale ranging from 'not efficient at all' (1) to 'highly efficient' (10) is provided.

  38. Evaluation of the referral consultation

    Time frame: Baseline

    Questionnaire comprising 6 items. The items are scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).

  39. Evaluation of the eHealth programme

    Time frame: 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).

  40. Recommendation of the eHealth programme

    Time frame: 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.

  41. Evaluation of the follow up consultation

    Time frame: 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).

  42. Self-rated global health change

    Time frame: 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).

  43. Self-rated global health change

    Time frame: 3 months after end of treatment

    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).

  44. Adverse events

    Time frame: 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

  45. Adverse events

    Time frame: 3 months after end of treatment

    Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity

  46. Quality-adjusted life year (QALY)

    Time frame: 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.

  47. Changes in health care use

    Time frame: 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

  48. Changes in productivity costs

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisbeth Frostholm, PhD

CONTACT

[email protected]

Marianne Rosendal, PhD

CONTACT

[email protected]

+4521476826

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)

Acronym: eASY

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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