Creation and Validation of a Questionnaire to Measure the Feelings of a Chronic Renal Insufficiency Person During His Hemodialysis

NCT02791828 | Unknown

• 1 other identifier: PR16030
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of three treatment sessions per week extrarenal lasting 4 hours each. This treatment is necessary but it has an impact on the quality of life of patients.The investigators believe that to improve the overall quality of life in hemodialysis patients, the quality of each hemodialysis session must be improved. The quality criterion is not only medical, it must also take into account the patient's perception about the course of its meeting : that's what we call quality of experience of the dialysis session. Our daily healthcare practice shows that each hemodialysis session is experienced differently by the patient according to different factors : physical, psychological, relational, technical, temporal. The quality of the experience of a hemodialysis session could be positively influenced by the use of supplements occupational assets or liabilities, for improving patient satisfaction or by enhancing its relationship with the staff. Indeed, a preliminary study ( in the nephrology unit of our establishment in January 2012) of 8 patients undergoing active occupational educational activity during hemodialysis, showed that the experience of the hemodialysis session was potentially improvable (experienced patients improved, reduced cramps ... ). However, to assess the impact of such measures on the lives of the dialysis session and the quality of life in general, the investigators need to measure the quality of living of a dialysis session. There is not, at present, specific tool to measure the quality of the experience of a hemodialysis session. This tool would measure the impact of a caregiver support occupational during dialysis sessions. The main objective of this study is to create and validate an instrument to measure the quality of living of a hemodialysis of chronic renal insufficiency subject.

Conditions

Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• quality of life of a hemodialysis of chronic renal insufficiency subject

  3 years

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

Patients will be recruited volunteers hemodialysis centers

You may qualify if:

• Will be included in the study , patients :
• From 18 years or more;
• Achieved with chronic renal failure;
• Under hemodialysis;
• fluent in French .
• With a social security scheme.
• Will not be included in the study , patients :
• Having cognitive problems hindering understanding of the tool.
• Having participated in Phase I of the research project.
• Under Backup Justice (guardianship)."

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sylvette KHAZNADJI

CONTACT

326789298; skhaznadji@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 7, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 7, 2016

Record last verified: 2016-05

Locations

FR (1)