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Trial record 1 of 1 for:    NCT01830803
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Reliability of howRU and howRwe Questionnaires

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ClinicalTrials.gov Identifier: NCT01830803
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Henk Bilo, MD, Medical Research Foundation, The Netherlands

Brief 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 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.


Condition or disease
Quality of Life

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.


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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Reliability of howRU and howRwe Questionnaires
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HowRU and HowRwe physician scores [ Time Frame: 1 day ]
    The agreement and concordance between patient scores and treating physician/nurse practioner scores on both the howRU and the howRwe questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Visiting the general practice in the period of February/March to May 2013

Exclusion Criteria:

  • Illiteracy
  • Insufficient understanding of the Dutch language
  • Mental retardation
  • Visual impairments, such that the questionnaires can not be read

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830803


Locations
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Netherlands
General Practice Blanker en Thiele
Zwolle, Overijssel, Netherlands, 8016 LC
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
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Principal Investigator: Jojanneke Rutgers, Bsc Unaffiliated/RUG?
Study Director: Marco Blanker, MD, PhD University Medical Center of Groningen, department of general practice
Study Director: Hans van Hateren, MD, PhD Diabetes Center Isala Clinics, Zwolle, the Netherlands

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henk Bilo, MD, MD PhD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01830803     History of Changes
Other Study ID Numbers: HowRU/we/1
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Keywords provided by Henk Bilo, MD, Medical Research Foundation, The Netherlands:
howRU
howRwe
reliability
quality of life
quality of care
patient satisfaction