No registrations found.
ID
Source
Health condition
Patients with Chronic Obstructive Pulmonary Disease (COPD) + their resident loved ones.
Sponsors and support
Ciro+, centre of expertise for chronic organ failure
Boehringer Ingelheim Nederland
Intervention
Outcome measures
Primary outcome
The resident loved one, their perception of the person with COPD, and the person with COPD will be compared by using the:
1. Problematic ADLs using the Canadian Occupational Performance Measure (COPM);
2. COPD Assessment Test (CAT);
3. mMRC dyspnea scale;
4. Short-Form 12;
5. Instrumental Activities of Daily Living Scale (IADLS);
6. EQ-5D;
7. Fatigue using the Subjective Fatigue subscale of the Checklist Individual Strength;
8. Self-efficacy for home walking.
Secondary outcome
The secondary study parameters will be:
1. Hospital Anxiety and Depression scale (HADS);
2. Care Dependency Scale (CDS);
3. Daily symptoms checklist;
4. Current smoking status and smoking history;
5. Fat-free mass (using BIA), body weight and height;
6. Physical activity (using validated accelerometer);
7. Informal and professional (medical) care <6 months;
8. Perceived social support using the Medical Outcome Study Social Support Survey (MOSSSS);
9. Post-bronchodilator spirometry;
10. Blood pressure, heart rate and oxygen saturation at rest;
11. Timed-up-and-go test;
12. Utrecht Coping List;
13. Caregiver burden and positive aspects of caregiving using the FACQ-PC;
14. A 35-item COPD knowledge questionnaire (self-developed, currently tested);
15. Dutch relationship questionnaire 2003 (Uitgever: Pearson Assessment and Information B.V.).
Other study parameters will be:
16. Demographics, including marital status;
17. Data on relationship of the loved one to the patient;
18. Medical history;
19. Current medication;
20. Charlson co-morbidity index.
Background summary
Background of the study:
Resident loved ones (mostly spouses or resident family members) are uniquely positioned to witness the abilities/limitations that patients with Chronic Obstructive Pulmonary Disease (COPD) experience during day-to-day life. Moreover, resident loved ones can play an important role in COPD patients’ management and well-being. To date, limited data are available specifically focussing on the resident loved ones' perception of the COPD patient’s health status, the resident loved ones' lifestyle and their possible interaction. Furthermore, loved ones' burden and health in relation to exacerbation-related hospital admission of the person with COPD are not investigated until now.
Primary objectives:
1.1 To investigate the differences between patients’ and resident loved ones' perceptions of patients’ health status and problematic ADLs. 1.2 To study prospectively the effects of an acute COPD exacerbation on resident loved ones' perceptions of patients’ health status and problematic ADLs.
Study design:
The Home Sweet Home study is an observational, longitudinal study.
Study population:
The study population consist of 192 persons with COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II, III and IV) and one resident loved one for each person with COPD.
Primary study parameters/outcome of the study:
The resident loved one, their perception of the person with COPD, and the person with COPD will be compared by using the : • Problematic ADLs using the Canadian Occupational Performance Measure (COPM) • COPD Assessment Test (CAT) • mMRC dyspnea scale • Short-Form 12 • Instrumental Activities of Daily Living Scale (IADLS) • EQ-5D • Fatigue using the Subjective Fatigue subscale of the Checklist Individual Strength • Self-efficacy for home walking.
Study objective
1. To investigate the differences between patients’ and resident loved ones' perceptions of patients’ health status and problematic ADLs;
2. To study prospectively the effects of an acute COPD exacerbation on resident loved ones' perceptions of patients’ health status and problematic ADLs.
Study design
Baseline and after 12 months. Only for patients who are admitted to the hospital because of an exacerbation, 2 additional visits are planned. The first visit, only for the loved one, within 7 days after hospital admission of the patient. The other visit, for both the patient and loved one, within 2 weeks after hospital discharge.
Intervention
N/A
CIRO+, centre of expertise for chronic organ failure<br>
Hornerheide 1
Martijn A. Spruit
Horn 6085 NM
The Netherlands
+31 (0)475 587726
martijnspruit@ciro-horn.nl
CIRO+, centre of expertise for chronic organ failure<br>
Hornerheide 1
Martijn A. Spruit
Horn 6085 NM
The Netherlands
+31 (0)475 587726
martijnspruit@ciro-horn.nl
Inclusion criteria
1. COPD as main diagnosis (GOLD stage II, III or IV according to GOLD guidelines);
2. No exacerbation or hospitalization <4 weeks before enrolment;
3. Providing written informed consent;
4. One resident loved one also provided a written informed consent to participate.
Exclusion criteria
1. Unable to complete the study questionnaires because of cognitive impairment as determined by the ‘Short Blessed Test’, for both the patient as well as the loved one;
2. Unable to speak or understand Dutch, for both the patient as well as the loved one.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3776 |
| NTR-old | NTR3941 |
| CCMO | NL42721.060.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41466 |