Quality of Life in Patients With Chronic Disease

NCT03925805 | Completed

• 1 other identifier: B670201939629
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 1

Brief Summary

To improve HRQoL in patients with chronic diseases, a comprehensive understanding of the association between HRQoL and chronic diseases is vital. Therefore, the aim of the study is to provide a profound insight in HRQoL outcomes and its determinants in chronically ill patients, with a focus on multimorbidity and socio-economic status in a primary care setting.

Conditions

Chronic Disease; Quality of Life; Cardiovascular Diseases; Diabetes; Mental Disorder; Musculoskeletal Disease

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life (EQ-5D-5L)

  Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.

  Measured at one time point (inclusion)

• Self-perceived health status (SF-12)

  This study will use the 12-item Short Form Health Survey (SF-12) as a generic subjective or self-perceived health status instrument to assess patient's functional health and well-being whereas both physical and mental functioning components can be measured. This study makes use of the 12-item version instead of the 36-item version, because it can be completed in a shorter time. This instrument contains 12 items including eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) which can be easily completed in five minutes. The summary scores, on a scale from 0 to 100, will be calculated to represent physical (Physical Component Summary score) and mental functioning (Mental Component Summary score). Higher scores indicate better self-perceived health status. The SF-12 has been confirmed as a valid and reliable instrument for measuring health perception in a general population for primary care.

  Measured at one time point (inclusion)

Secondary Outcomes (8)

• Sense of coherence (SOC-13)

  Measured at one time point (inclusion)

• Self-efficacy (GSES)

  Measured at one time point (inclusion)

• Health literacy (HLS-EU-Q6)

  Measured at one time point (inclusion)

• Patient enablement (PEI)

  Measured at one time point (inclusion)

• Social support (F-SozU)

  Measured at one time point (inclusion)

Study Arms (1)

Chronic disease

Cardiovascular disease (including diabetes), mental disease, musculoskeletal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any chronic disease that fits in the three major disease groups, can be included. The selection of these specific disease groups was determined by a literature search. It was found that these disease groups result in a lower quality of life compared to other diseases.

You may qualify if:

• Study participants have to be adults (aged 18 years or older).
• Study participants need to be medically diagnosed with one (or more) diseases of the following three non-infectious disease groups, in various degrees of severity:cardiovascular disorders (including diabetes), mental disorders, and musculoskeletal disorders.
• Study participants must have been followed by their general practitioner for at least six months.
• Study participants must have good understanding of Dutch to be able to complete the questionnaire and to give informed consent.

You may not qualify if:

• Study participants with a major cognitive impairment will be excluded.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Lisa Van Wilder

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Chronic Disease; Cardiovascular Diseases; Diabetes Mellitus; Mental Disorders; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Delphine De Smedt, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health and Primary Care

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: November 12, 2019
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

BE (1)