Quality of LifeNCT01830803
Reliability of howRU and howRwe Questionnaires
An observational study of Quality of Life, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial summary
Quality of life and patient satisfaction are two important concepts in health care, especially in chronic diseases. Currently, there are several instruments available to determine this, but many are not easily applicable in daily practice because of their length and the consequential effort they require from both… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2013to May 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting a general practice will be asked to participate. We will select patients based on their scores on the howRU and howRwe questionnaires. We will aim to include at least 90 patients: a minimum of 30 patients with diabetes, 30 COPD patients and 30 persons without these diseases.
Who may be able to join
- 18 years of age or older
- Visiting the general practice in the period of February/March to May 2013
Who cannot join
- Illiteracy
- Insufficient understanding of the Dutch language
- Mental retardation
- Visual impairments, such that the questionnaires can not be read
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
General Practice Blanker en Thiele
Zwolle, Overijssel, 8016 LC
About this study
Quality of life and patient satisfaction are two important concepts in health care, especially in chronic diseases. Currently, there are several instruments available to determine this, but many are not easily applicable in daily practice because of their length and the consequential effort they require from both patients and caregivers.
In the UK, Benson et al. recently developed two short generic patient questionnaires on quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both questionnaires contain four items.
Read more
The howRU questionnaire has already been validated and seems highly applicable to be used in large patient groups. The howRwe questionnaire has not been validated yet. The reliability of both questionnaires has not been assessed either. The procedure as suggested by Kocks et al. provides us with the opportunity to perform a reliability procedure on patient level.
The purpose of this study is to assess the reliability of the howRU and the howRwe questionnaires on patient level in the Dutch population.
Read the detailed description
Prior to the start of this study, the howRU and howRwe questionnaires have been translated into Dutch by the MAPI-institute.
All possible eligible patients who are visiting the general practice between February 2013 and April 2013 are asked to complete the howRU questionnaire prior to consultation and the howRwe questionnaire directly after consultation. The scores are not shown to the health care provider who will also complete both questionnaires after consultation as he/she thought the patient should have completed the questionnaires.
An investigator will then select patients based on the scores on the howRU and howRwe questionnaires and their diseases. We will aim to include at least 90 patients: a minimum of 30 patients with diabetes, 30 COPD patients and 30 persons without these diseases. For each patient category, a maximum of 15 patients with a maximum score (defined as 10-12) will be included. All other patients need to have lower scores. As this study aims to assess the reliability of the questionnaires, it is not necessary to select the study participants at random.
The selected patients will be asked to participate in our study. Participating patients will be asked to fill in other questionnaires (EQ-5D and Europep) and the investigator will hold semi-structured interviews, preferably on the day of consultation. Patients are asked to comment on each separate concept of the questionnaires. They are asked what thoughts they had during the completion of the individual questions, and are asked to give examples of these.
The participants' opinions about the questionnaires will also be asked. All interviews will be recorded and fully transcribed. All references to scores on individual items of the questionnaire (in number or words) will be covered with black bars to blind these results. These elaboration will be sent to a reviewing panel consisting of 45 clinicians and 45 patients. They will be instructed to complete the howRU and howRwe questionnaires of a patient, the way they thought the patient should have rated the questionnaires based on the interview, gender and age. Each interview has to be reviewed and scored by five separate clinicians and five patients for both howRU and howRwe.
Each set of interviews, that will be sent out for review, will contain 10 randomly assigned interviews, including information on the patients' gender and age. The order in which interviews will be in the package will be randomised to prevent fatigue of the reviewers and learning effects in the interviews performed later in sequence. Additionally, all interviews will be sent to a panel of patients. These patients will be selected by an investigator.
For statistical analysis SPSS will be used. The data will be manually entered twice to check for errors. The agreement between patient score, treating physician/nurse practitioner and reviewing panel will be presented in Bland \& Altman plots for both the howRU and howRwe questionnaires. To assess normality Q-Q plot will be used.
The concordance between patient scores, treating physician/practice nurse scores, and the mean of the scores of the reviewing clinicians and patients will be studied by Lin's concordance correlation (CCC), an extended intraclass correlation (ICC). Additionally, the scores of the five reviewing clinicians will be compared to the scores of the patient panel, also using the ICC.
- Conditions
- Quality of Life
- Keywords
- howRU, howRwe, reliability, quality of life, quality of care, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HowRU/HowRwe | All participants will fill out the HowRwe and HowRU questionnaires. Although this questionnaire may be considered an intervention, it is not the goal of this study to investigate the questionnaires as an intervention but to investigate whether they are reliable questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability HowRU and HowRwe
This primary outcome measure concerns the scores on the howRU and howRwe questionnaires as filled out by the patients and the reviewing panel.
Measured: Average 12 weeks
Secondary outcomes (1)
HowRU and HowRwe physician scores
The agreement and concordance between patient scores and treating physician/nurse practioner scores on both the howRU and the howRwe questionnaires.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henk Bilo, MD, Medical Research Foundation, The Netherlands
- Investigators
- Jojanneke Rutgers, Bsc, Principal investigator, Unaffiliated/RUG?Marco Blanker, MD, PhD, Study director, University Medical Center of Groningen, department of general practiceHans van Hateren, MD, PhD, Study director, Diabetes Center Isala Clinics, Zwolle, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830803
- Sponsor's protocol ID
- HowRU/we/1
- Status last verified
- Mar 2018
- First submitted
- 5 Apr 2013
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Benson T, Sizmur S, Whatling J, Arikan S, McDonald D, Ingram D. Evaluation of a new short generic measure of health status: howRu. Inform Prim Care. 2010;18(2):89-101. doi: 10.14236/jhi.v18i2.758.
PubMed 21078231Kocks JW, Kerstjens HA, Snijders SL, de Vos B, Biermann JJ, van Hengel P, Strijbos JH, Bosveld HE, van der Molen T. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level. Health Qual Life Outcomes. 2010 Nov 16;8:135. doi: 10.1186/1477-7525-8-135.
PubMed 21080960Hendriks SH, Rutgers J, van Dijk PR, Groenier KH, Bilo HJ, Kleefstra N, Kocks JW, van Hateren KJ, Blanker MH. Validation of the howRu and howRwe questionnaires at the individual patient level. BMC Health Serv Res. 2015 Oct 2;15:447. doi: 10.1186/s12913-015-1093-8.
PubMed 26431695
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of howRU and howRwe Questionnaires
- ClinicalTrials.gov ID
- NCT01830803
- Acronym / sponsor ID
- HowRU/we/1
- Conditions
- Quality of Life
- Keywords
- howRU, howRwe, reliability, quality of life, quality of care, patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Apr 2013 (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.
Quality of life and patient satisfaction are two important concepts in health care, especially in chronic diseases. Currently, there are several instruments available to determine this, but many are not easily applicable in daily practice because of their length and the consequential effort they require from both patients and caregivers.
In the UK, Benson et al. recently developed two short generic patient questionnaires on quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both questionnaires contain four items.
The howRU questionnaire has already been validated and seems highly applicable to be used in large patient groups. The howRwe questionnaire has not been validated yet. The reliability of both questionnaires has not been assessed either. The procedure as suggested by Kocks et al. provides us with the opportunity to perform a reliability procedure on patient level.
The purpose of this study is to assess the reliability of the howRU and the howRwe questionnaires on patient level in the Dutch population.
Detailed description
Prior to the start of this study, the howRU and howRwe questionnaires have been translated into Dutch by the MAPI-institute.
All possible eligible patients who are visiting the general practice between February 2013 and April 2013 are asked to complete the howRU questionnaire prior to consultation and the howRwe questionnaire directly after consultation. The scores are not shown to the health care provider who will also complete both questionnaires after consultation as he/she thought the patient should have completed the questionnaires.
An investigator will then select patients based on the scores on the howRU and howRwe questionnaires and their diseases. We will aim to include at least 90 patients: a minimum of 30 patients with diabetes, 30 COPD patients and 30 persons without these diseases. For each patient category, a maximum of 15 patients with a maximum score (defined as 10-12) will be included. All other patients need to have lower scores. As this study aims to assess the reliability of the questionnaires, it is not necessary to select the study participants at random.
The selected patients will be asked to participate in our study. Participating patients will be asked to fill in other questionnaires (EQ-5D and Europep) and the investigator will hold semi-structured interviews, preferably on the day of consultation. Patients are asked to comment on each separate concept of the questionnaires. They are asked what thoughts they had during the completion of the individual questions, and are asked to give examples of these.
The participants' opinions about the questionnaires will also be asked. All interviews will be recorded and fully transcribed. All references to scores on individual items of the questionnaire (in number or words) will be covered with black bars to blind these results. These elaboration will be sent to a reviewing panel consisting of 45 clinicians and 45 patients. They will be instructed to complete the howRU and howRwe questionnaires of a patient, the way they thought the patient should have rated the questionnaires based on the interview, gender and age. Each interview has to be reviewed and scored by five separate clinicians and five patients for both howRU and howRwe.
Each set of interviews, that will be sent out for review, will contain 10 randomly assigned interviews, including information on the patients' gender and age. The order in which interviews will be in the package will be randomised to prevent fatigue of the reviewers and learning effects in the interviews performed later in sequence. Additionally, all interviews will be sent to a panel of patients. These patients will be selected by an investigator.
For statistical analysis SPSS will be used. The data will be manually entered twice to check for errors. The agreement between patient score, treating physician/nurse practitioner and reviewing panel will be presented in Bland \& Altman plots for both the howRU and howRwe questionnaires. To assess normality Q-Q plot will be used.
The concordance between patient scores, treating physician/practice nurse scores, and the mean of the scores of the reviewing clinicians and patients will be studied by Lin's concordance correlation (CCC), an extended intraclass correlation (ICC). Additionally, the scores of the five reviewing clinicians will be compared to the scores of the patient panel, also using the ICC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HowRU/HowRwe | – | –All participants will fill out the HowRwe and HowRU questionnaires. Although this questionnaire may be considered an intervention, it is not the goal of this study to investigate the questionnaires as an intervention but to investigate whether they are reliable questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting a general practice will be asked to participate. We will select patients based on their scores on the howRU and howRwe questionnaires. We will aim to include at least 90 patients: a minimum of 30 patients with diabetes, 30 COPD patients and 30 persons without these diseases.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Visiting the general practice in the period of February/March to May 2013
Key exclusion criteria (4 listed)
- Illiteracy
- Insufficient understanding of the Dutch language
- Mental retardation
- Visual impairments, such that the questionnaires can not be read
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability HowRU and HowRwe
Time frame: Average 12 weeks
This primary outcome measure concerns the scores on the howRU and howRwe questionnaires as filled out by the patients and the reviewing panel.
1 secondary outcome
HowRU and HowRwe physician scores
Time frame: 1 day
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 21 Mar 2018.
- Background: PubMed 21078231Benson T, Sizmur S, Whatling J, Arikan S, McDonald D, Ingram D. Evaluation of a new short generic measure of health status: howRu. Inform Prim Care. 2010;18(2):89-101. doi: 10.14236/jhi.v18i2.758.
- Background: PubMed 21080960Kocks JW, Kerstjens HA, Snijders SL, de Vos B, Biermann JJ, van Hengel P, Strijbos JH, Bosveld HE, van der Molen T. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level. Health Qual Life Outcomes. 2010 Nov 16;8:135. doi: 10.1186/1477-7525-8-135.
- Derived from this study: PubMed 26431695Hendriks SH, Rutgers J, van Dijk PR, Groenier KH, Bilo HJ, Kleefstra N, Kocks JW, van Hateren KJ, Blanker MH. Validation of the howRu and howRwe questionnaires at the individual patient level. BMC Health Serv Res. 2015 Oct 2;15:447. doi: 10.1186/s12913-015-1093-8.
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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.
Jojanneke Rutgers, Bsc principal investigator
Unaffiliated/RUG?
Marco Blanker, MD, PhD study director
University Medical Center of Groningen, department of general practice
Hans van Hateren, MD, PhD study director
Diabetes Center Isala Clinics, Zwolle, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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 2 inclusion and 4 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 21 Mar 2018. 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 Netherlands. 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?
Reliability HowRU and HowRwe (time frame: Average 12 weeks). 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 NCT01830803, which also lists 3 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 21 Mar 2018.