Persistent Physical SymptomsNCT05287087
My Symptoms - Feasibility Study
A study testing My Symptoms 1 (MySt-1) and My Symptoms 2 (MySt-2) in people with Persistent Physical Symptoms, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The proposed project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.minesymptomer.dk. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Physical Symptoms
- What is being tested?
- My Symptoms 1 (MySt-1) and My Symptoms 2 (MySt-2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Mar 2022to 30 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Listed with participating practice
- Giving informed consent to participation in the study
- Consulting a GP or GP supervised staff
- Multiple symptoms, i.e. 4 or more symptoms within the past 4 weeks, according to the Bodily Distress Syndrome checklist (a validated symptom checklist with 25 items)
Who cannot join
- Not consulting for symptoms
- Symptoms are due to acute disease
- Symptoms must primarily be treated by medicine or surgery
- Not eligible due to language or cognitive problems
- Patient severely affected by other disease
- Other, GP assessment/statement (e.g.: All symptoms are with recent onset and I see no need for intervention at present, I do not believe the patient will benefit the least bit from participation in the eHealth programme at this time)
Show all 10Show fewer
- Patient declines to use the eHealth program despite GP recommendation
- Patient has not accessed the programme within 2 weeks from referral from the GP
- Criteria for stratification:
- Long-term sick leave, i.e. more than 8 weeks, will be a criterion for stratification in order to enable analyses on the target group of patients with PPS without chronicity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: My Symptoms - Feasibility Study: Feasibility of Intervention and Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care for Persistent Symptoms in Primary Care
The proposed project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.minesymptomer.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. In order to improve health care for patients with PPS, the investigators have developed a web-based selfhelp programme for symptoms. As part of the intervention, this programme is prescribed by the patient's general practitioner (GP). 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 and how it affects GPs in routine care and patients in daily life. With this study, the investigators wish to take the first step towards a comprehensive and rigorous evaluation. Results from this feasibility study will both qualify a subsequent randomised controlled trial (RCT) in a larger pilot study and provide information for a potential national dissemination.
Read the detailed description
Drawing on existing evidence about symptoms, functional disorders and eHealth interventions combined with user involvement, the investigators have developed a web-based self-help programme for PPS: "My Symptoms". The programme builds on the bio-psycho-socialexistential illness model and enhanced cognitive behavioural theory. Seven treatment modules focus on psychoeducation, lifestyle intervention, self-regulation and graded exercise delivered through text, videos, animations and audio files (see overview of content in table 1). Furthermore, it includes a 1-day course for GPs and a mandatory follow-up appointment between patient and GP at the programme closure. The training course for the GPs will focus on patient identification, positive reinforcement and familiarity with the content of the programme. The programme must be prescribed by GPs and is recommended to use for 6 weeks.
The objectives with the present feasibility study are: 1) to test and refine the GP training course, 2) to explore the planned logistics for patient recruitment, 3) to evaluate GP and patient questionnaires, and 4) to evaluate patients' use of the programme and 5) follow-up consultations with their GP.
With regard to 2-5, the following questions will be adressed and explored:
- Which modifications are needed to the predefined procedures for consecutive patient enrolment?
- What are the results of patient enrolment with respect to recruitment rates and patient characteristics? (Patients are asked and screened consecutively, but how many accept participation and fulfil inclusion criteria? What characterises enrolled patients compared to refusers?)
- To what extent do patients accept and engage with the baseline research questionnaires?
- When do included patients engage with the programme after enrolment (delay in time)?
- How much do included patients interact with the intervention, i.e. how many patients log into the program, which modules and pages are accessed, and how many tools are used?
- How many patients consult the GP for a follow-up consultation and when does this consultation take place?
- How many contacts do the patients have to participating practices during their use of the programme?
Alongside this part of the feasibility study, the investigators will conduct a separate in-depth qualitative study (field study observations and interviews) on GP and patient interactions with the intervention. A separate protocol has been developed for this part of the feasibility study.
- Conditions
- Persistent Physical Symptoms
- Being tested
- My Symptoms 1 (MySt-1), My Symptoms 2 (MySt-2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Symptoms 1 (MySt-1)Behavioural
The patients will get access to an eHealth programme consisting of:
- A questionnaire including the BDS checklist
- A brief introductory animation about how to understand symptoms in general
- Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.
- A brief animation about the interaction of body and mind.
These four provisions are identical to the first part of the MySt-2.
My Symptoms 2 (MySt-2)Behavioural
The patients will get access to an eHealth programme consisting of:
- A questionnaire including the BDS checklist
- A brief introductory animation about how to understand symptoms in general
- Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease.
- A brief animation about the interaction of body and mind.
- Thorough symptom explanations
- Physical energy (focus on sleep, diet and activity)
- Values and choices (focus on meaning and existential issues)
- Emotional health (focus on emotion regulation)
- Mental energy (focus on stress regulation and thinking)
After 4-6 weeks, the patient will see the GP for a follow-up consultation.
| Study group | Role | What they receive |
|---|---|---|
| My Symptoms 1 (MySt-1) | Active comparator | GPs will receive an introduction to the overall content of the eHealth programme MySt-1. The information will be given to participating GPs and their staff during a 1½-hour session in the practice. The research assistant will go through the logistics of the patient recruitment and evaluation step-by-step and GPs and relevant staff will subsequently have access to the programme.
The patients will get access to a basic eHealth programme (My Symptoms 1). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. Receives: Behavioral: My Symptoms 1 (MySt-1) |
| My Symptoms 2 (MySt-2) | Experimental | GPs will attend a one-day training course of 7 hours including: in depth insight into the My Symptoms 2 eHealth programme, comprehensive understanding of PPS, training of communication skills and the use of contextual (non-specific/common psychological) factors. The training programme has been developed in cooperation with the national GP association offering CME (PLO-e). Lecturers and trainers will be GPs and psychologists from the research team.
The patients will get access to an advanced eHealth programme (My Symptoms 2). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. Receives: Behavioral: My Symptoms 2 (MySt-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in the target age group visiting the practice
Measured: Recruitment (Week 1)
Number of patients refusing participation
Measured: Recruitment (Week 1)
Number of patients fulfilling the inclusion criteria
Measured: Recruitment (Week 1)
Number of patients excluded by the GPs and reasons for this
Measured: Recruitment and/or referral consultation (Week 1-3 expectedly)
Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs)
Measured: Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)
Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs)
Measured: 2 weeks after referral consultation (Week 4-5 expectedly)
Secondary outcomes (17)
Symptoms
Bodily Distress Syndrome checklist
Measured: Recruitment (screening), programme login (baseline), end of treatment
Symptom intensity and interference
Measured: Recruitment (screening), programme login (baseline), end of treatment
Illness perception
Illness Perception Questionnaire
Measured: Recruitment (screening), programme login (baseline), end of treatment
Anxiety and Depression
Symptom Checklist (SCL)-13
Measured: Recruitment (screening), programme login (baseline), end of treatment
Health anxiety
Whiteley-6R
Measured: Recruitment (screening), programme login (baseline), end of treatment
Global health
One item from SF-36
Measured: Recruitment (screening), programme login (baseline), end of treatment
Evaluation of GP at referral consultation
6 items
Measured: Programme login (baseline)
Program expectations
2 items adapted from the Credibility Expectancy Questionnaire
Measured: Programme login (baseline)
Quality of life
SF-36
Measured: Programme login (baseline), end of treatment
Quality of life
EQ-5D-5L (EuroQol)
Measured: Programme login (baseline), end of treatment
Pain self-efficacy
Pain Self-Efficacy Questionnaire
Measured: Programme login (baseline), end of treatment
Illness behavior
The Behavioural Responses to Illness Questionnaire
Measured: Programme login (baseline), end of treatment
Productivity Costs
Productivity Costs Questionnaire (IMTA)
Measured: Programme login (baseline), end of treatment
Health care utilization
Medical Consumption Questionnaire (IMTA)
Measured: Programme login (baseline), end of treatment
Program evaluation
13 items
Measured: End of treatment
Global impression of change
1 item
Measured: End of treatment
Evaluation of GP at referral consultation
2 items
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start31 Mar 2022
- Primary completion30 Sep 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Physical SymptomsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Rosendal, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287087
- Sponsor's protocol ID
- 1-10-72-372-21
- Status last verified
- Feb 2024
- First submitted
- 10 Mar 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Symptoms - Feasibility Study: Feasibility of Intervention and Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care for Persistent Symptoms in Primary Care
- ClinicalTrials.gov ID
- NCT05287087
- Acronym / sponsor ID
- 1-10-72-372-21
- Conditions
- Persistent Physical Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- 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.
The proposed project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.minesymptomer.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. In order to improve health care for patients with PPS, the investigators have developed a web-based selfhelp programme for symptoms. As part of the intervention, this programme is prescribed by the patient's general practitioner (GP). 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 and how it affects GPs in routine care and patients in daily life. With this study, the investigators wish to take the first step towards a comprehensive and rigorous evaluation. Results from this feasibility study will both qualify a subsequent randomised controlled trial (RCT) in a larger pilot study and provide information for a potential national dissemination.
Detailed description
Drawing on existing evidence about symptoms, functional disorders and eHealth interventions combined with user involvement, the investigators have developed a web-based self-help programme for PPS: "My Symptoms". The programme builds on the bio-psycho-socialexistential illness model and enhanced cognitive behavioural theory. Seven treatment modules focus on psychoeducation, lifestyle intervention, self-regulation and graded exercise delivered through text, videos, animations and audio files (see overview of content in table 1). Furthermore, it includes a 1-day course for GPs and a mandatory follow-up appointment between patient and GP at the programme closure. The training course for the GPs will focus on patient identification, positive reinforcement and familiarity with the content of the programme. The programme must be prescribed by GPs and is recommended to use for 6 weeks.
The objectives with the present feasibility study are: 1) to test and refine the GP training course, 2) to explore the planned logistics for patient recruitment, 3) to evaluate GP and patient questionnaires, and 4) to evaluate patients' use of the programme and 5) follow-up consultations with their GP.
With regard to 2-5, the following questions will be adressed and explored:
- Which modifications are needed to the predefined procedures for consecutive patient enrolment?
- What are the results of patient enrolment with respect to recruitment rates and patient characteristics? (Patients are asked and screened consecutively, but how many accept participation and fulfil inclusion criteria? What characterises enrolled patients compared to refusers?)
- To what extent do patients accept and engage with the baseline research questionnaires?
- When do included patients engage with the programme after enrolment (delay in time)?
- How much do included patients interact with the intervention, i.e. how many patients log into the program, which modules and pages are accessed, and how many tools are used?
- How many patients consult the GP for a follow-up consultation and when does this consultation take place?
- How many contacts do the patients have to participating practices during their use of the programme?
Alongside this part of the feasibility study, the investigators will conduct a separate in-depth qualitative study (field study observations and interviews) on GP and patient interactions with the intervention. A separate protocol has been developed for this part of the feasibility study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Symptoms 1 (MySt-1) | Active comparator | Behavioral: My Symptoms 1 (MySt-1)GPs will receive an introduction to the overall content of the eHealth programme MySt-1. The information will be given to participating GPs and their staff during a 1½-hour session in the practice. The research assistant will go through the logistics of the patient recruitment and evaluation step-by-step and GPs and relevant staff will subsequently have access to the programme. The patients will get access to a basic eHealth programme (My Symptoms 1). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. |
| My Symptoms 2 (MySt-2) | Experimental | Behavioral: My Symptoms 2 (MySt-2)GPs will attend a one-day training course of 7 hours including: in depth insight into the My Symptoms 2 eHealth programme, comprehensive understanding of PPS, training of communication skills and the use of contextual (non-specific/common psychological) factors. The training programme has been developed in cooperation with the national GP association offering CME (PLO-e). Lecturers and trainers will be GPs and psychologists from the research team. The patients will get access to an advanced eHealth programme (My Symptoms 2). The programme is an internet-delivered self-help programme supporting patients' selfefficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Listed with participating practice
- Giving informed consent to participation in the study
- Consulting a GP or GP supervised staff
- Multiple symptoms, i.e. 4 or more symptoms within the past 4 weeks, according to the Bodily Distress Syndrome checklist (a validated symptom checklist with 25 items)
Key exclusion criteria (10 listed)
- Not consulting for symptoms
- Symptoms are due to acute disease
- Symptoms must primarily be treated by medicine or surgery
- Not eligible due to language or cognitive problems
- Patient severely affected by other disease
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 |
|---|---|---|
| My Symptoms 1 (MySt-1)The patients will get access to an eHealth programme consisting of: 1. A questionnaire including the BDS checklist 2. A brief introductory animation about how to understand symptoms in general 3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease. 4. A brief animation about the interaction of body and mind. These four provisions are identical to the first part of the MySt-2. | Behavioural | My Symptoms 1 (MySt-1) |
| My Symptoms 2 (MySt-2)The patients will get access to an eHealth programme consisting of: 1. A questionnaire including the BDS checklist 2. A brief introductory animation about how to understand symptoms in general 3. Basic information on symptom in general and on six common symptoms: headache, fatigue, dizziness, pain, dyspepsia and abdominal unease. 4. A brief animation about the interaction of body and mind. 5. Thorough symptom explanations 6. Physical energy (focus on sleep, diet and activity) 7. Values and choices (focus on meaning and existential issues) 8. Emotional health (focus on emotion regulation) 9. Mental energy (focus on stress regulation and thinking) After 4-6 weeks, the patient will see the GP for a follow-up consultation. | Behavioural | My Symptoms 2 (MySt-2) |
Primary outcome
Number of patients in the target age group visiting the practice
Time frame: Recruitment (Week 1)
Number of patients refusing participation
Time frame: Recruitment (Week 1)
Number of patients fulfilling the inclusion criteria
Time frame: Recruitment (Week 1)
Number of patients excluded by the GPs and reasons for this
Time frame: Recruitment and/or referral consultation (Week 1-3 expectedly)
Number of patients not accepting the invitation for intervention despite consent to participate in the project (drop-outs)
Time frame: Invitation for referral consultation/at referral consultation (Week 1-3 expectedly)
Number of patients who do not log into the programme within 2 weeks from referral or only log into the programme once (drop-outs)
Time frame: 2 weeks after referral consultation (Week 4-5 expectedly)
17 secondary outcomes
Symptoms
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Symptom intensity and interference
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Illness perception
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Anxiety and Depression
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Health anxiety
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Global health
Time frame: Recruitment (screening), programme login (baseline), end of treatment
Evaluation of GP at referral consultation
Time frame: Programme login (baseline)
Program expectations
Time frame: Programme login (baseline)
Quality of life
Time frame: Programme login (baseline), end of treatment
Quality of life
Time frame: Programme login (baseline), end of treatment
Pain self-efficacy
Time frame: Programme login (baseline), end of treatment
Illness behavior
Time frame: Programme login (baseline), end of treatment
Productivity Costs
Time frame: Programme login (baseline), end of treatment
Health care utilization
Time frame: Programme login (baseline), end of treatment
Program evaluation
Time frame: End of treatment
Global impression of change
Time frame: End of treatment
Evaluation of GP at referral consultation
Time frame: End of treatment
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 23 Feb 2024.
- Program access for patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Symptoms 1 (MySt-1) and My Symptoms 2 (MySt-2) in people with Persistent Physical Symptoms, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 10 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 23 Feb 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 Denmark. 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?
Number of patients in the target age group visiting the practice (time frame: Recruitment (Week 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024.