Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000112864
Ethics application status
Approved
Date submitted
19/01/2012
Date registered
24/01/2012
Date last updated
28/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Southern Adelaide Co-ordinated Regional Hip and Debility Rehabilitation Programme
Scientific title
SACRED - Southern Adelaide Co-ordinated Regional Hip and Debility Rehabilitation Programme to Improve Quality of Life,
Secondary ID [1] 279761 0
Nil
Universal Trial Number (UTN)
Trial acronym
SACRED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 285626 0
Condition category
Condition code
Physical Medicine / Rehabilitation 285818 285818 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention developed for this study will closely resemble interdisciplinary approaches routinely delivered to older adults with hip fracture who return to community living, geriatric hip fracture programs and early supported discharge programs. The program run will include a: - Medical assessment by a Geriatrician prior to discharge if possible and post discharge at residential facility. - Review of medications and comorbidities by a Geriatrician prior to discharge if possible and post discharge at residential facility. - Following discharge participants will receive 4 weeks of physiotherapy focused on restoration of transfers and limited mobility with a Physiotherapist and Allied Health Assistant. Other allied health assessment and support, including dietetics assessment, will be provided as required. In addition, we will work with aged care staff to encourage a rehabilitation approach between formal therapy sessions and we will set up a formal meeting with families to discuss progress and relevant issues.
Intervention code [1] 284078 0
Rehabilitation
Comparator / control treatment
Participants allocated to this group will continue treatments (which may include sessions of physiotherapy) according to usual practice in the nursing home. The control group on all sites will receive orthogeriatric care in hospital and medical care from a general practitioner after discharge. Research staff will record therapy and other services offered to controls to allow description of differences in experiences of the groups as currently recommended in rehabilitation trials.
Control group
Active

Outcomes
Primary outcome [1] 286332 0
Quality of Life
The 28-item DEMQOL and 31-item DEMQOL-Proxy are generic measures of health related quality of life which have been developed specifically for older people with dementia and their carers. It is recommended that both measures are used together as they give different but complementary perspectives on quality of life in dementia.

The DEMQOL is appropriate for use in mild to moderate dementia. The DEMQOL system has been validated in the UK in a large sample of people with dementia and their carers and allows outcomes assessment across a wide range of severity in dementia.
Timepoint [1] 286332 0
Baseline- 1 month post randomisation-12 months post randomisation
Primary outcome [2] 286333 0
Primary Outcome 2 is now EQ-5D-5L. The EQ-5D-5L is a standardised instrument used as a measure of health outcome (Herdman M et al 2011) and will be administered during the trial at the same time points as the Dem-QoL and Dem-QoL proxy in order to obtain a measure of health status for this population which can be compared with individual responses to the Dem-Qol and can also be used to compare health status for this population with other patient groups internationally. Indexed based values are a major feature of this instrument, facilitating the calculation of quality-adjusted life years that are used to inform economic evaluations of health care interventions.
Timepoint [2] 286333 0
Baseline-1 month post randomisation- 12 month post randomisation
Primary outcome [3] 287043 0
Mobility Autonomy The Nursing Home Life Space Diameter is a measure of the extent and frequency of mobility developed specifically for use in the aged care setting with reports of high intra-rater (0.922) and inter-rater (0.951) reliability and moderate positive correlation with other functional characteristics such as participation in social activities, dressing, eating and bathing. The survey consists of four diameters scored on a scale of 0 to 5 and weighted to result in possible scores ranging from 0 (bed- or chair-bound) to 50 (signifying leaving the facility daily).
Timepoint [3] 287043 0
Pre-morbid- Baseline-1 month post randomisation- 12 month post randomisation
Secondary outcome [1] 295617 0
Activities of Daily Living Level of independence in activities of daily living will be assessed using the Modified Barthel Index, a simple and rapid measure of function with high reliability (0.90). This survey contains 10 items, each scored from unable to perform task to fully independent, a total score of 100 indicating complete independence. The survey will be administered to the primary care giving staff at the hospital to determine status following surgical fixation of their hip fracture prior to randomisation, and then again at the aged care facility 4 weeks folllowing randomisation.
Timepoint [1] 295617 0
Pre-morbid - Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [2] 295618 0
[2]* Depression The Cornell Scale for Depression in Dementia (CSDD) is a 19 item depression screening instrument specifically designed to determine whether a person with dementia has depression and has been used in clinical trials in this setting. Factor analysis suggests there are four subscales: depression, somatic/vegetative, disturbed sleep and anxiety. A modified version is currently used by residential aged care staff when completing the ACFI (The Aged Care Funding Instrument) which informs the funding models for residential aged care.
Timepoint [2] 295618 0
Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [3] 295619 0
Cognition: MMSE
The Mini-Mental State Examination (MMSE) is a widely used screening test for cognitive impairment in older adults. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
Timepoint [3] 295619 0
Baseline-1 month post randomisation- 12 months post randomisation
Secondary outcome [4] 295620 0
Delirium
The Confusion Assessment Method (CAM) is a quick and simple method of screening patients in order to detect delirium. The CAM consists of a series of reflective questions which require some interpretation, followed by an algorithm based on the central features of delirium. The CAM is easy to use, it takes less than five minutes to complete after training in its use and it is well validated.
Timepoint [4] 295620 0
Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [5] 295621 0
[5]* Nutrition The Mini Nutritional Assessment (MNA) is an easily and rapidly administered nutritional assessment tool consisting of four main components: anthropometric measurements (BMI and self reported weight loss), global assessment (lifestyle, medication and mobility), dietary assessment (number of meals, protein and fluid intake) and subjective assessment (self-rated health and nutrition) (Saletti, 2000). The MNA score can be used to classify patients as well-nourished, at risk of malnutrition or malnourished and has been demonstrated to be useful in following nutritional status in patients with Alzheimers disease (Nourhashemi et al. 1999).
Timepoint [5] 295621 0
Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [6] 295622 0
Pain
The Pain Assessment IN Advanced Dementia (PAINAD) (Warden et al. 2003; Leong, 2006). This scale requires 5 minutes of observation and is a 5 item scale (breathing, negative vocalizations, facial expression, body language and consolability) scored 0 (no pain) to 10 (severe pain).
Timepoint [6] 295622 0
Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [7] 295623 0
Medications
The Medication Appropriateness Index (MAI)(Samsa et al. 1994) assesses the appropriateness of a medication on 10 criteria: indication, effectiveness, dosage, correct directions, practical directions, drug-drug interactions, drug-disease interactions, duplications, duration and expense. The assessment is made by a pharmacist from the case notes and medication charts. We have used this instrument in previous trials (n=145(Crotty et al. 2004) and n=110(Miller et al. 2006)).
Timepoint [7] 295623 0
Baseline - 1 month Post Randomization
Secondary outcome [8] 295624 0
Recovery
The Functional Recovery Scale (FRS) (Koval and Zuckerman, 1994) is a disease specific functional instrument developed specifically for hip fracture patients. This tool assesses independence of participants with respect to their ADLs including their level of mobility indoors and outdoors and their level of transportation.
Timepoint [8] 295624 0
Baseline - 1 month Post Randomization - 12 months Post Randomization
Secondary outcome [9] 297262 0
The Therapeutic Environment Screening Scale (TESS-NH)(Sloane et al. 2002) will be used to assess the environmental setting of the participants within their high level care facility. This instrument designed for residents with dementia includes items such as noise, lighting as well as assessing the interaction of staff with residents. Scores range from 0-166 with higher scores indicating a more therapeutic environment.
Timepoint [9] 297262 0
4 weeks post randomisation
Secondary outcome [10] 297263 0
Medical events, pharmaceutical usage and adverse events. Adverse events will be dealt with according to best practice procedures if they occur in a timely fashion but also information collected as below: 1. Falls and Injuries: Aged care facility records will be audited at 1 and 12 months. Serious injuries will be defined as those resulting in fracture, or admission to hospital, and will be confirmed against hospital records. Moderate injuries will include events requiring GP visits. Mortality: The name, gender, date of birth and elements of address will be matched to the National Death Index held by the Australian Institute of Health and Welfare to extract mortality.
In addition MBS and PBS data will be collected to inform medical interventions and pharmaceutical usage during the 12 months post randomisation.
Timepoint [10] 297263 0
1 month post randomisation-12 months post randomisation.
Secondary outcome [11] 309645 0
Qualitative data. Attitudes and perceptions of carers (both paid carers and family carers). Family and nursing home staff for the first 30 participants recruited to the trial will be invited to attend an interview or focus group to share their perceptions regarding the journey for residents who live in nursing homes and suffer a hip fracture.
In addition, nursing home staff who care for those participants who are allocated to the intervention arm of the trial will be invited to provide comments at 1 week and 4 weeks post randomisation regarding their perceptions of any benefits, concerns or challenges related to the provision of the inreach rehabilitation.
Timepoint [11] 309645 0
4 weeks post randomisation.

Eligibility
Key inclusion criteria
Inclusion criteria for participants include the following:
- Recent hip fracture (proximal femoral fracture) treated surgically
- Aged 70+ years
- Living in aged care facility (nursing home) within the catchments of the local hospital prior to injury
- Ambulant prior to fracture either without assistance, with aids, or with the assistance of one other person
- Medically stable and ready for discharge.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants are the following:
- Unable to provide informed consent or gain this from a suitable proxy
- Pathological and peri-prosthetic fractures
- Terminal illness and receiving palliative care
- Hip fracture treated non surgically
- Severe cognitive impairment, unable to follow a one step command at recruitment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent and baseline measures participants will be randomised to the control or intervention . Randomisation will be managed by a pharmacist external to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
4/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2788 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 2789 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [3] 2790 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 284546 0
Government body
Name [1] 284546 0
NHMRC - National Health and Medical Research Council
Country [1] 284546 0
Australia
Primary sponsor type
Government body
Name
NHMRC - National Health and Medical Research Council
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 283472 0
University
Name [1] 283472 0
Flinders University
Address [1] 283472 0
Rehab, Aged and Extented Care
GPO Box 2100
ADELAIDE SA 5001
Country [1] 283472 0
Australia
Other collaborator category [1] 260465 0
University
Name [1] 260465 0
University of Sydney
Address [1] 260465 0
The University of Sydney
NSW 2006
Australia
Country [1] 260465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286531 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286531 0
Ethics committee country [1] 286531 0
Australia
Date submitted for ethics approval [1] 286531 0
20/01/2012
Approval date [1] 286531 0
Ethics approval number [1] 286531 0
Application Number: 020.12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33658 0
Prof Maria Crotty
Address 33658 0
Rehab. Aged and Extended Care Flinders University GPO Box 2100 ADELAIDE SA 5001
Country 33658 0
Australia
Phone 33658 0
+61 8 8275 1103
Fax 33658 0
+61 8 8275 1130
Email 33658 0
[email protected]
Contact person for public queries
Name 16905 0
Maria Crotty
Address 16905 0
Rehab. Aged and Extended Care Flinders University GPO Box 2100 ADELAIDE SA 5001
Country 16905 0
Australia
Phone 16905 0
+61 8 8275 1103
Fax 16905 0
+61 8 8275 1130
Email 16905 0
[email protected]
Contact person for scientific queries
Name 7833 0
Maria Crotty
Address 7833 0
Rehab. Aged and Extented Care
Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 7833 0
Australia
Phone 7833 0
+61 8 8275 1103
Fax 7833 0
+61 8 8275 1130
Email 7833 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe chaotic journey: Recovering from hip fracture in a nursing home2016https://doi.org/10.1016/j.archger.2016.07.004
EmbaseShould we provide outreach rehabilitation to very old people living in Nursing Care Facilities after a hip fracture? A randomised controlled trial.2019https://dx.doi.org/10.1093/ageing/afz005
EmbasePeople living in nursing care facilities who are ambulant and fracture their hips: description of usual care and an alternative rehabilitation pathway.2020https://dx.doi.org/10.1186/s12877-019-1321-x
N.B. These documents automatically identified may not have been verified by the study sponsor.