- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01382251
Functional Recovery and Caregiver Burden Following Surgery in the Elderly (FOCUS)
The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.
The primary objective of this study is to:
Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.
Secondary objectives are to determine if:
- Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.
- Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
- Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).
Přehled studie
Postavení
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Ontario
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Ottawa, Ontario, Kanada, K1Y 4E9
- The Ottawa Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Patients
- aged 65 years and older
- elective surgery with a planned discharge to the community on the day of the surgical procedure.
- Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy.
Caregiver
- spouses, family members, or friends identified as the patient's primary source of support in the community.
Exclusion Criteria:
Patients
- Reside in a nursing home providing professional support services;
- Are unable to complete the study instruments due to cognitive (MMSE <24) or physical impairment;
- Are unable to speak English or French
Caregiver
- Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient;
- Unable to complete the study instruments due to physical impairment;
- Unable to Speak English or French
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Patient
Patients undergoing ambulatory surgery
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Caregiver
Spouse, family members, or friends identified as the patient's primary source of support in the community.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Functional Autonomy Measurement System (SMAF)
Časové okno: Baseline, one week, and one month following surgery
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29-item scale, each item graded on a four-point scale.
0= independent, 1= needs supervision,2 = needs help, 3 = dependent.
Total score ranges from 0 to 87 with higher scores indicating increased disability
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Baseline, one week, and one month following surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Zarit Burden Interview (ZBI)
Časové okno: Baseline, one week, and one month following surgery
|
A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving.
Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always."
Scores range from 0-88 with higher scores indicating increased burden of care.
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Baseline, one week, and one month following surgery
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Short Form 12
Časové okno: Baseline, one week, and one month following surgery
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A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week.
Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.
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Baseline, one week, and one month following surgery
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Brief Pain Inventory (BPI) Functional Interference Score.
Časové okno: Baseline, one week, and one month following surgery
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Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity.
Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes."
The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.
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Baseline, one week, and one month following surgery
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gregory L Bryson, FRCPC, Department of Anesthesiology, The Ottawa Hospital
Publikace a užitečné odkazy
Obecné publikace
- Bryson GL, Clavel NA, Moga R, Power B, Taljaard M, Nathan HJ. Patient function and caregiver burden after ambulatory surgery: a cohort study of patients older than 65. Can J Anaesth. 2013 Sep;60(9):864-73. doi: 10.1007/s12630-013-9982-y. Epub 2013 Jun 15.
- Bryson GL, Mercer C, Varpio L. Patient and caregiver experience following ambulatory surgery: qualitative analysis in a cohort of patients 65 yr and older. Can J Anaesth. 2014 Nov;61(11):986-94. doi: 10.1007/s12630-014-0229-3. Epub 2014 Sep 9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2009390-01H
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