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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05562765
Other study ID # BAIBU-SBF-SDE-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date December 30, 2019

Study information

Verified date May 2018
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date December 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
A descriptive characteristics form, the General Comfort Scale and Quality of Life Index Cardiac Version-IV was used to collect data.

Locations

Country Name City State
Turkey cardiology clinic of a university hospital in Bolu Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comfort level 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)
Primary Quality of life level 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)
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