Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762941
Other study ID # SHS-ED-06-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date July 31, 2019

Study information

Verified date September 2020
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Elderly dependent on homecare, admitted acutely, are fragile. The aim of this study is to investigate the difference in the definition and rating of Quality of Life (QoL) among acute admitted elderly i) with and ii) without homecare background.


Description:

The study is designed as a cross sectional study and will be conducted at three Emergency Departments (ED) within the Region of Southern Denmark; Hospital of Southern Jutland, Hospital of Southwest Jutland and Hospital Lillebaelt. The study method is based on a QoL questionnaire preformed as a structured interview with elderly who are acutely admitted in an ED.

Elderly persons who meet the inclusion criteria will be invited to participate during their admission. Written information about this study will be handed from the nurse in the ED. If the elderly accept she/he will get further oral information from the researcher. Written consent will be obtained if the elderly wish to participate.

Including patients from three different EDs will presumably provide a broad selection, with elderly persons who live both in the city and in rural areas and thereby representing a general sample of the Danish population.There may be a variation in cause of hospitalization related to seasonal changes. To present a broad selection, the inclusion period will involve summer, fall, and winter. Inclusion and all structured interviews will be performed during admission by two persons: the responsible researcher and a research assistant.

Primary Outcome:

The primary outcome QoL will be accessed and evaluated by the Schedule for the Evaluation of Individual Quality of Life - direct weighting (SEIQoL-DW).

Exposure:

Homecare: Receiving "personal" homecare for more than 2 hours per week. Furthermore numbers of hours of homecare a week will be registered for each participant to see if there is any difference in QoL connected to number of hours.

Readmission: Readmissions 30 days after discharge from the primary index admission (yes/no). Readmission is defined as; an unscheduled hospitalization for any reason and where the patient has stayed at the hospital overnight within 30 days after discharge from the index admission.

The outcomes and variables will be collected through;

At a structured interview during hospitalization; The Ph.D student and the research assistant are responsible for conducting the interviews. The patients will at the interview be asked about; Aspect and index score of QoL, cognitive functioning (OMC score), marital status, length of education and social support.

In the patients' records during hospitalization; The Ph.D student is responsibility for collecting following information in the patients' record; Last admission, hours of homecare, use of home nursing, primary reason for hospitalization and comorbidities. Patients will be asked specific for permission to access journal data. Variables from the patients' record will be extracted after the informed consent for participation is obtained. The information from the journal will be handled from health professionals in the ED.

In the patients' record 30 days after discharge; Variables after 30 days will be counted from the discharge form the index admission. The Ph.D student is responsibility for collecting the information in the patient record about readmission and length of hospital stay under the same terms as described above.

Instrument

The primary outcome QoL are accessed and evaluated by SEIQoL-DW which are assessed in a structured interview. First the interviewer elicits five areas of life considered most important by the participant. Secondly, the participant rates the level each of these areas from worst possible to best possible on a visual analogue scale (SEIQoL - VAS) and thirdly the participant is asked for the relative importance of each area by a direct weighting (DW) procedure. The DW procedure uses a pie chart consisting of five coloured segments. Each colour represents an area chosen by the respondent. The areas can be adjusted in size to reflect the relative importance of each area (greatest importance is the largest pie area). The total value of all five segments equals 100. To calculate the participants QoL at the moment, each area will be divided by 100. By multiplying the level of the area by the weight for each area and adding up the values for each area, a SEIQoL-DW index score will be calculated.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Patients (aged = 65 year) admitted to EDs at the Hospital of Southern Jutland, Hospital of Southwest Jutland or Hospital Lillebaelt

Exclusion Criteria:

- Patients unable to give informed consent to participate

- Patients known or believed to be cognitively impaired as assessed by the OMC test (score > 18 point).

- Patients who only receive outpatient treatment in the ED will be excluded

- Patients with an inadequate understanding of written and spoken Danish (assessed by the health professionals at the ED).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Hospital of Southern Jutland Aabenraa The Region Of Southern Denmark

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual Quality of life accessed and evaluated by a structured interview The primary outcome is QoL measured as an index score (range from 0 [lowest QoL] to 100 [highest QoL]). d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A