NCT05562765

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

October 3, 2022

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

September 28, 2022

Last Update Submit

September 28, 2022

Conditions

Keywords

comfortquality of lifecardiac patientsnursingolder patients

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Interventions

SurveyOTHER

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of individuals aged 65 and over with cardiovascular disease.

You may qualify if:

  • were to be 65 years and older,
  • have a diagnosis of CVDs,
  • speak and understand Turkish,
  • can communicate verbally.

You may not qualify if:

  • hearing impairments and cognitive limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cardiology clinic of a university hospital in Bolu

Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Şeyma Demir Erbaş

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assist

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

August 1, 2018

Primary Completion

August 30, 2019

Study Completion

December 30, 2019

Last Updated

October 3, 2022

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations