NCT01830803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

April 5, 2013

Last Update Submit

March 20, 2018

Conditions

Quality of Life

Keywords

howRUhowRwereliabilityquality of lifequality of carepatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Average 12 weeks

Secondary Outcomes (1)

  • HowRU and HowRwe physician scores

    1 day

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Practice Blanker en Thiele

Zwolle, Overijssel, 8016 LC, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 21078231BACKGROUND

  • Kocks 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.

    PMID: 21080960BACKGROUND

  • Hendriks 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.

    PMID: 26431695DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jojanneke Rutgers, Bsc

    Unaffiliated/RUG?

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 12, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

NL(1)