Disability EvaluationNCT01611129
Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
A study testing Internet-based counseling in people with Disability Evaluation, run by Thomas Lunner at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability Evaluation
- What is being tested?
- Internet-based counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2012to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages over 18 years old
- Have symptoms of hearing difficulty
- Access to internet
Who cannot join
- HHQ results too low (i.e., below 20),
- Participants using hearing aids
- Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
The Swedish Institute for Disability Research, Linköping University
Linköping, 58185
United Kingdom1 site
Department of Vision and Hearing Sciences, Anglia Ruskin University
Swansea, CB1 1PT
About this study
Official title: Use of the 'Patient Journey' Model in the Internet-based Pre-fitting Counseling of a Person With Hearing Impairment: A Randomized Controlled Trial
The purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.
- Conditions
- Disability Evaluation
- Being tested
- Internet-based counseling
- Keywords
- Disability Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based counselingBehavioural
Stage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented. The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI \& CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management.
| Study group | Role | What they receive |
|---|---|---|
| reading about hearing loss and its management | Active comparator | General self-reading reading about hearing loss and its management This would run for 30 days and the participants have to manage their own time. Receives: Behavioral: Internet-based counseling |
| Internet-based counseling | Experimental | This would involve 4 stages of designated internet sessions and additional tasks which the patients can complete in their own time. This programme should be completed within 30 days. Receives: Behavioral: Internet-based counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Questionnaire (HHQ)
Change from baseline in reported emotional and social consequences due to hearing impairment one week post treatment.
Hearing Handicap Questionnaire (HHQ) - Change from baseline
Measured: One week pre-treatment, One week post treatment, Six-moths follow-up
Secondary outcomes (3)
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in reported depression and anxiety symptoms one week post treatment.
Hospital Anxiety and Depression Scale (HADS) - Change from baseline
Measured: One week pre-treatment, One week post treatment, Six moths follow-up
University of Rhode Island Change Assessment Scale (URICA)
Change from baseline in readiness for change one week post treatment. University of Rhode Island Change Assessment Scale (URICA) - Change from baseline.
Measured: One week pre-treatment, One week post treatment, Six months follow-up
Hearing Impairment Acceptance Questionnaire (HIAQ)
Change from baseline in acceptance of hearing loss one week post treatment. Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.
Measured: One week pre-treatment, One week post treatment, Six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disability EvaluationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Lunner
- Sponsor type
- Other government
- Collaborators
- Swansea University
- Responsible party
- Sponsor-investigator, Thomas Lunner, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611129
- Sponsor's protocol ID
- FAS-IT-03
- Status last verified
- Apr 2013
- First submitted
- 14 May 2012
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manchaiah VK, Stephens D, Andersson G, Ronnberg J, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials. 2013 Jan 24;14:25. doi: 10.1186/1745-6215-14-25.
PubMed 23347711Manchaiah V, Ronnberg J, Andersson G, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial. BMC Ear Nose Throat Disord. 2014 Apr 7;14(1):3. doi: 10.1186/1472-6815-14-3.
PubMed 24708677
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the 'Patient Journey' Model in the Internet-based Pre-fitting Counseling of a Person With Hearing Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01611129
- Acronym / sponsor ID
- FAS-IT-03
- Conditions
- Disability Evaluation
- Keywords
- Disability Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Thomas LunnerOther government
- Collaborators
- Swansea University
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Jun 2012 (estimated)
- 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 purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reading about hearing loss and its management | Active comparator | Behavioral: Internet-based counselingGeneral self-reading reading about hearing loss and its management This would run for 30 days and the participants have to manage their own time. |
| Internet-based counseling | Experimental | Behavioral: Internet-based counselingThis would involve 4 stages of designated internet sessions and additional tasks which the patients can complete in their own time. This programme should be completed within 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages over 18 years old
- Have symptoms of hearing difficulty
- Access to internet
Key exclusion criteria (3 listed)
- HHQ results too low (i.e., below 20),
- Participants using hearing aids
- Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program
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 |
|---|---|---|
| Internet-based counselingStage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented. The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI \& CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management. | Behavioural | Internet-based counseling, reading about hearing loss and its management |
Primary outcome
Hearing Handicap Questionnaire (HHQ)
Time frame: One week pre-treatment, One week post treatment, Six-moths follow-up
Change from baseline in reported emotional and social consequences due to hearing impairment one week post treatment. Hearing Handicap Questionnaire (HHQ) - Change from baseline
3 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: One week pre-treatment, One week post treatment, Six moths follow-up
University of Rhode Island Change Assessment Scale (URICA)
Time frame: One week pre-treatment, One week post treatment, Six months follow-up
Hearing Impairment Acceptance Questionnaire (HIAQ)
Time frame: One week pre-treatment, One week post treatment, Six months follow-up
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 17 Apr 2013.
- Background: PubMed 23347711Manchaiah VK, Stephens D, Andersson G, Ronnberg J, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials. 2013 Jan 24;14:25. doi: 10.1186/1745-6215-14-25.
- Derived from this study: PubMed 24708677Manchaiah V, Ronnberg J, Andersson G, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial. BMC Ear Nose Throat Disord. 2014 Apr 7;14(1):3. doi: 10.1186/1472-6815-14-3.
- Related InfoLink provided by the sponsor.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based counseling in people with Disability Evaluation, run by Thomas Lunner at 2 sites in 2 countries.
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 3 inclusion and 3 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, United Kingdom. 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?
Hearing Handicap Questionnaire (HHQ) (time frame: One week pre-treatment, One week post treatment, Six-moths follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611129, which also lists 2 linked publications.
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 17 Apr 2013.