Activities of Daily LivingFOCUSNCT01382251
Functional Recovery and Caregiver Burden Following Surgery in the Elderly
An observational study of Activities of Daily Living and Caregivers, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Activities of Daily Living, Caregivers, Ambulatory Surgical Procedures
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jan 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Older adult
Study population: Patients undergoing ambulatory surgery and their primary caregivers
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Keywords
- Activities of Daily Living, Caregivers, Ambulatory Surgical Procedures
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 |
|---|---|---|
| Patient | Patients undergoing ambulatory surgery | |
| Caregiver | Spouse, family members, or friends identified as the patient's primary source of support in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Autonomy Measurement System (SMAF)
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
Measured: Baseline, one week, and one month following surgery
Secondary outcomes (3)
Zarit Burden Interview (ZBI)
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.
Measured: Baseline, one week, and one month following surgery
Short Form 12
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.
Measured: Baseline, one week, and one month following surgery
Brief Pain Inventory (BPI) Functional Interference Score.
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.
Measured: Baseline, one week, and one month following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Responsible party
- Sponsor
- Investigators
- Gregory L Bryson, FRCPC, Principal investigator, Department of Anesthesiology, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382251
- Sponsor's protocol ID
- 2009390-01H
- Acronym
- FOCUS
- Status last verified
- Dec 2013
- First submitted
- 23 Jun 2011
- Last updated
- 20 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23771742Bryson 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.
PubMed 25200593
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery and Caregiver Burden Following Surgery in the Elderly
- ClinicalTrials.gov ID
- NCT01382251
- Acronym / sponsor ID
- FOCUS / 2009390-01H
- Keywords
- Activities of Daily Living, Caregivers, Ambulatory Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Patients undergoing ambulatory surgery |
| Caregiver | – | –Spouse, family members, or friends identified as the patient's primary source of support in the community. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing ambulatory surgery and their primary caregivers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
Functional Autonomy Measurement System (SMAF)
Time frame: 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
3 secondary outcomes
Zarit Burden Interview (ZBI)
Time frame: Baseline, one week, and one month following surgery
Short Form 12
Time frame: Baseline, one week, and one month following surgery
Brief Pain Inventory (BPI) Functional Interference Score.
Time frame: Baseline, one week, and one month following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23771742Bryson 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.
- Derived from this study: PubMed 25200593Bryson 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.
Related trials for Activities of Daily Living
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Evaluation of the PPAL
Age Problems
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
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.
Gregory L Bryson, FRCPC principal investigator
Department of Anesthesiology, The Ottawa Hospital
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 Activities of Daily Living and Caregivers, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 6 inclusion and 8 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 20 Jan 2014. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Autonomy Measurement System (SMAF) (time frame: Baseline, one week, and one month following surgery). 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 NCT01382251, which also lists 2 linked publications.
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 20 Jan 2014.