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Functional Recovery and Caregiver Burden Following Surgery in the Elderly (FOCUS)

17. december 2013 opdateret af: Ottawa Hospital Research Institute

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).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

123

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Ontario
  - Ottawa, Ontario, Canada, K1Y 4E9
    - The Ottawa Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients undergoing ambulatory surgery and their primary caregivers

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Patient Patients undergoing ambulatory surgery
Caregiver Spouse, family members, or friends identified as the patient's primary source of support in the community.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Functional Autonomy Measurement System (SMAF) Tidsramme: Baseline, one week, and one month following surgery	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	Baseline, one week, and one month following surgery

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Zarit Burden Interview (ZBI) Tidsramme: 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.	Baseline, one week, and one month following surgery
Short Form 12 Tidsramme: Baseline, one week, and one month following surgery	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.	Baseline, one week, and one month following surgery
Brief Pain Inventory (BPI) Functional Interference Score. Tidsramme: Baseline, one week, and one month following surgery	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.	Baseline, one week, and one month following surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Samarbejdspartnere

Canadian Anesthesiologists' Society

Efterforskere

Ledende efterforsker: Gregory L Bryson, FRCPC, Department of Anesthesiology, The Ottawa Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

23. juni 2011

Først indsendt, der opfyldte QC-kriterier