Quality of LifeNCT03762941
Quality of Life Among Acute Admitted Elderly
An observational study of Quality of Life, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality of Life
- How many people
- 406 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: Elderly persons who meet the inclusion criteria will be invited to participate during their admission.
Who may be able to join
- Patients (aged ≥ 65 year) admitted to EDs at the Hospital of Southern Jutland, Hospital of Southwest Jutland or Hospital Lillebaelt
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hospital of Southern Jutland
Aabenraa, The Region of Southern Denmark, 6200
About this study
Official title: Is There a Difference in the Definition and Rating of Quality of Life Among Acute Admitted Elderly i) With and ii) Without Homecare Background: A Cross Sectional Study
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.
Read the detailed 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.
- Conditions
- Quality of Life
- Keywords
- Elderly patients, Emergency Department, Homecare
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients acutely admitted | Elderly patients (aged ≥ 65 year) admitted to emergency departments at the Hospital of Southern Jutland or Odense University |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Aug 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Elkjær, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762941
- Sponsor's protocol ID
- SHS-ED-06-2018
- Status last verified
- Sep 2020
- First submitted
- 27 Jun 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elkjaer M, Primdahl J, Mogensen CB, Brabrand M, Gram B. The quality of life of older adults acutely admitted to the emergency department: A cross-sectional study. Nurs Open. 2022 Jul;9(4):2130-2138. doi: 10.1002/nop2.1223. Epub 2022 Apr 30.
PubMed 35488717
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference in the Definition and Rating of Quality of Life Among Acute Admitted Elderly i) With and ii) Without Homecare Background: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03762941
- Acronym / sponsor ID
- SHS-ED-06-2018
- Conditions
- Quality of Life
- Keywords
- Elderly patients, Emergency Department, Homecare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients acutely admitted | – | –Elderly patients (aged ≥ 65 year) admitted to emergency departments at the Hospital of Southern Jutland or Odense University |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly persons who meet the inclusion criteria will be invited to participate during their admission.
Key inclusion criteria (1 listed)
- Patients (aged ≥ 65 year) admitted to EDs at the Hospital of Southern Jutland, Hospital of Southwest Jutland or Hospital Lillebaelt
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individual Quality of life accessed and evaluated by a structured interview
Time frame: d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.
The primary outcome is QoL measured as an index score (range from 0 [lowest QoL] to 100 [highest QoL]).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 35488717Elkjaer M, Primdahl J, Mogensen CB, Brabrand M, Gram B. The quality of life of older adults acutely admitted to the emergency department: A cross-sectional study. Nurs Open. 2022 Jul;9(4):2130-2138. doi: 10.1002/nop2.1223. Epub 2022 Apr 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Elkjær principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual Quality of life accessed and evaluated by a structured interview (time frame: d) QoL are measured during admission(expected inclusions period: 1 year). Data are reported ½ year after the end of inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.