- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05562765
Comfort and Quality of Life of Older Cardiac Patients
September 28, 2022 updated by: Seyma Demir, Abant Izzet Baysal University
Comfort and Quality of Life of Older Cardiac Patients: A Cross-sectional Study
The aims of the study were to determine the comfort and quality of life, to examine the relationship between them, and to identify factors that affect the comfort and quality of life in older cardiac patients.
The cross-sectional study was conducted in the inpatient cardiology clinic of a university hospital in Bolu.
Overall, 209 patients, who met the inclusion criteria, consisted of the sample.
A descriptive characteristics form, the General Comfort Scale and Quality of Life Index Cardiac Version-IV was used to collect data.
The study was reported in The Strengthening the Reporting of Observational Studies in Epidemiology Statement.
Mean of the General Comfort Scale scores was 16.18±0.82,
and the mean of the Turkish Quality of Life Index (QLI) Cardiac Version-IV scores was 2.97±0.39.
Physical, psycho-spiritual, environmental, and sociocultural comfort levels associated with both the general QLI Cardiac Version-IV scale and sub-dimensions of its (p<0.05).
The location of residence, perception of income status, frequency of hospitalization, dietary adherence, routine health control, and dizziness were the independent variables associated with the General Comfort and Quality of Life scale (p<0.05).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
209
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bolu, Turkey, 14280
- cardiology clinic of a university hospital in Bolu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population consisted of individuals aged 65 and over with cardiovascular disease.
Description
Inclusion Criteria:
- were to be 65 years and older,
- have a diagnosis of CVDs,
- speak and understand Turkish,
- can communicate verbally.
Exclusion Criteria:
- hearing impairments and cognitive limitations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comfort level
Time Frame: when recruited (once)
|
General Comfort Questionnaire (GCQ) was used to measure comfort level of older people.
The GCQ involves 48 items and a 4-point Likert structure that evaluates comfort dimension and level.
Dimensions of comfort include physical (12 items), psycho-spiritual (13 items), environmental (13 items), and sociocultural dimensions (10 items).
The comfort levels include relief (16 items), ease (17 items), and transcendence (15 items).
the scores that can be obtained from the scale range from 48 to 192.
The mean value is determined by dividing the total scores obtained by the number of scale items.
Comfort points range from 1 (low comfort) to 4 (high comfort).
|
when recruited (once)
|
|
Quality of life level
Time Frame: when recruited (once)
|
The Turkish Quality of Life Index (QLI) Cardiac Version-IV was used to measure quality of life (QoL) level of older people.
The scale consists of two fundamental section, each with 35 questions, and the 6-point Likert scale.
The scale has four main dimension: health and function, socio-economic, psychosocial/spiritual and family.
When scoring the scale, it was scored separately for each subsection.
Each answer given in relation to the satisfaction and importance section was multiplied by each other.
Then, all the results on the satisfaction and importance questions were added.
The possible score after this process was between -15 and +15 values.
To remove the negativity of this score, 15 was added to the possible score obtained for each individual.
In the scoring of the QLI Cardiac Version-IV, total score of 0 to 30 is obtained for each individual.
Higher scores indicate better QoL
|
when recruited (once)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Şeyma Demir Erbaş, Abant Izzet Baysal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
August 30, 2019
Study Completion (Actual)
December 30, 2019
Study Registration Dates
First Submitted
September 28, 2022
First Submitted That Met QC Criteria
September 28, 2022
First Posted (Actual)
October 3, 2022
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBU-SBF-SDE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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