Dementia Clinical Trial
Official title:
The Impact of Renovations in Long Term Care Living Spaces on Residents With Dementia, Their Families and the Staff That Care for Them
| NCT number | NCT04054583 |
| Other study ID # | E2016:084 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 9, 2017 |
| Est. completion date | March 31, 2021 |
| Verified date | September 2021 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
A long-term care facility in central Canada planned to renovate their existing dementia care units. The overarching objective of this study was to examine the effects of the renovations on residents, family, and staff.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | March 31, 2021 |
| Est. primary completion date | August 30, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Resident Inclusion Criteria: - Currently living on special care unit for residents with intermediate to advanced dementia or cognitive impairment in a long-term care facility Family Member Inclusion: - Must have a family member/friend/neighbour currently living on the special care unit. - For the QUALID, the family member must have visited the resident at least three out of the last seven days Family Member Exclusion Criteria: - Must be able to participate in-person. - Must be able to communicate in English. - Must be cognitively able to participate. Staff Inclusion Criteria: - Must currently work on the special care unit (either full or part-time or occasional) - For the survey, staff must be able to read and understand English. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Manitoba | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | Mitacs, Riverview Health Centre Foundation |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Process Evaluation | Documents (meeting minutes, training manuals, etc.) as well as staff interviews will be used to determine the context of units over the time of the renovation. For example, are there other changes occurring, beyond the renovation, that could have an effect on the residents, family and staff over the timeframe of the renovation project. | Prior to, during and after the renovation (approximately 2 years later or whenever renovations are complete) | |
| Primary | Satisfaction of Space on Resident Quality of Life and Family Interactions from Pre- to Post-renovation from Family Perspective Using Photovoice and Photo Elicitation | Family member's perspective regarding whether the renovations have had an effect on the resident's quality of life and the quality of their family's interactions with the resident. This will be gathered using photovoice (participant taken photos) and photo elicitation (researcher taken photos). In this method, both photo types will be discussed in one interview at pre- and one interview at post-renovation to gather impressions of the space and its impact on resident quality of life and family interactions. This is a qualitative research method. It will assess impressions at pre-renovations and at post-renovations. | Perspectives taken a pre- and post-renovation (approximately 2 years later or whenever renovations are complete). | |
| Primary | Changes in Space Utilization | Using a floor plan/map, observers will indicate the locations of occupants with a dot on a map and an activity code that indicates the behaviour of that person. Observations will occur every hour over 18 hours and over 6 days. This will show how the space is used before and after renovations. | Data will be collected for six months prior to and six months after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Primary | Changes in Building Occupant Satisfaction Survey of Staff | Staff perspective of how the space is used and functions before and after renovations. This survey measures variables such as overall environmental satisfaction, including satisfaction with acoustics, lighting, indoor air quality, and thermal comfort. Participants are also asked to provide descriptions of personal workspace, window proximity and workstation tenure, job satisfaction and demand, and method of working/time allocation. This survey has demonstrated reliability (Cronbach's alpha=0.728 to 0.873) and validity when compared with physical environment measures. There are no sub-scales. Each question will be evaluated independently. | Perspectives taken pre- and post-renovation (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Neuropsychiatric Symptoms of Residents from Six Months Prior to Renovation to Six Months Post-Renovation | Frequency of aggression or agitation as recorded in resident charts. | Measures will be collected six months prior to renovations and and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Physical Restraints of Residents from Six Months Prior to Renovation to Six Months Post-Renovation | Frequency of use of physical restraints as recorded in resident charts. | Measures will be collected six months prior to renovations and and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Anti-psychotic Medications and Sedatives with Residents from Six Months Prior to Renovation to Six Months Post-Renovation | Frequency of prescription of anti-psychotic medications and sedatives as recorded in resident charts. | Measures will be collected six months prior to renovations and and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Patient Safety Indicators of Residents from Six Months Prior to Renovations to Six Months Post-renovation: Frequency of medication errors and residents falls | Frequency of medication errors and residents falls as recorded in administrative records. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Sleep Records | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, the frequency of sleep record will be compared six months prior to the renovations and six months after renovations have been completed. Each resident's sleep status is recorded on an hourly basis throughout the night. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Aggressive Behaviour Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Aggressive Behaviour Scale (ABS) will be compared six months prior to the renovations and six months after renovations have been completed. Behaviour items used to calculate the ABS are: verbally abusive, physically abusive, socially inappropriate/disruptive behaviour, and resists care. Indicators of behavioural symptoms are recorded as part of the MDS assessments and are based upon the frequency of the behaviour within the last 7 days. The outcome scores range from 0-12 which are indicative of the following aggressive behaviour categories: 0=non, 1-2=moderate, 3-5=severe, and 6-12=very severe. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Cognitive Performance Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Cognitive Performance Scale (CPS) will be compared six months prior to the renovations and six months after renovations have been completed. The CPS is based on a predictive algorithm validated against the Mini-Mental State Examination. Scores of this scale range from 0 to 6, and identify the resident's level of impairment for the following 5 elements: comatose, short-term memory, cognitive skills for daily decision-making, making self understood, and eating. A higher score indicates increased impairment in cognitive function. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Change in Pain Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Pain Scale will be compared six months prior to the renovations and six months after renovations have been completed. This was developed to examine the prevalence of pain experienced by residents in nursing homes. It has been validated against the Visual Analogue Scale and has been shown to be valid in detecting pain. Scores range 0-3 with higher scores indicating a more severe pain experience. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Falls Risks Assessment Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Falls Risks Assessment Scale will be compared six months prior to the renovations and six months after renovations have been completed. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in the Index of Social Engagement Scale | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Index of Social Engagement Scale will be compared six months prior to the renovations and six months after renovations have been completed. Scores range 0-6 with higher scores indicating a higher level of social engagement. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Resident's Engagement Level using the Pool Activity Level (PAL) tool | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the PAL Tool will be compared six months prior to the renovations and six months after renovations have been completed. THE PAL Tool determines the person's current level of engagement and includes 4 activity levels: planned, exploratory, sensory, reflex. The PAL Checklist covers nine everyday activities: bathing/washing; getting dressed; eating; contact with others; group work skills; communication skills; practical activities (for example: craft, domestic chores, gardening); use of objects; and looking at a newspaper/magazine. Four descriptive statements are provided for each activity. The caregiver ticks the one that most accurately describes the individual's performance of that activity over the preceding two weeks. The number of statements selected for each level is totaled and the highest 'scoring' one indicates the individual's activity level. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Depression Rating Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Index of Depression Rating Scale will be compared six months prior to the renovations and six months after renovations have been completed. This scale suggests possible clinical depression warranting further investigation. Scores range 0-14 with a score of 3 or more may indicate a potential or actual problem with depressions. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Activities of Daily Living Self-Performance Hierarchy Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final score of the Activities of Daily Living (ADL) Self-performance Hierarchy Scale will be compared six months prior to the renovations and six months after renovations have been completed. This scale reflects the disablement process by grouping ADL performance levels into discrete stages of loss (this is, early loss: personal hygiene; middle loss: toileting and locomotion; late loss: eating). Scores range 0-6 with higher scores indicating greater decline (progressive loss) in ADL performance. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Activities of Daily Living Short Form Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Activities of Daily Living (ADL) Short Form Scale will be compared six months prior to the renovations and six months after renovations have been completed. This scale provides a measure of the resident's ADL self-performance status based on items that reflect stages of loss (early, middle and late loss). Scores range 0-16 with higher scores indicating more impairment of self-sufficiency in ADL Performance. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Functional and Health Status of Residents: Changes in Activities of Daily Living Long Form Scale Scores | Using the Resident Assessment Inventory - Minimum Data Set 2.0 (RAI-MDS) data, final scores of the Activities of Daily Living (ADL) Long Form Scale will be compared six months prior to the renovations and six months after renovations have been completed. This scale provides measure of the resident's ability to perform ADLs. The ADL Long Form is more sensitive to clinical changes than the other ADL scales. Scores range from 0-28 with higher scores indicating more impairment of self-sufficiency in ADL performance. RAI-MDS is a standardized measurement tool that is used in long term care facilities across Canada. | Measures will be collected six months prior to renovations and six months after renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Staffing from Pre- to Post-renovation: Worker's Compensation Board Claims | Aggregated human resources data will be gathered of the number and type of worker's compensation board claims of staff working on the special care unit from pre- to post-renovation. | Data will be collected for six months prior to and six months after the renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Staffing from Pre- to Post-renovation: Absenteeism | Aggregated human resources data will be gathered of the total number of hours and average number of hours when staff have been absent from work due to illness from pre- to post-renovation | Data will be collected for six months prior to and six months after the renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Staffing from Pre- to Post-renovation: Leave of Absence | Aggregated human resources data will be gathered of the total number of hours staff have taken a leave of absence for any reason from pre- to post-renovation. | Data will be collected for six months prior to and six months after the renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Staffing from Pre- to Post-renovation: Staff Retention | Aggregated human resources data will be gathered on the total number of staff who worked on the special care unit prior to the renovations and were still working on the unit at post-renovation. | Data will be collected for six months prior to and six months after the renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Staffing from Pre- to Post-renovation: Staff Turnover | Aggregated human resources data will be gathered on the total number of staff who worked on the special care unit prior to the renovations but were no longer working on the unit at post-renovation. | Data will be collected for six months prior to and six months after the renovations have been completed (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in the Quality of Life in Late Stage Dementia (QUALID) Scores of Residents | Quality of Life in Late stage Dementia (QUALID) questionnaire total score will be compared before and after renovations. The QUALID is completed by family who have visited a resident at least three of the last seven days. This is an 11-item interview that asks a family member or caregiver to rate how often a specific resident exhibits behaviours associated with quality of life (e.g., smiling, enjoying a meal). A 5-point scale captures the frequency of each item (total score ranging from 11 to 55). Lower scores reflected a higher quality of life (QOL). This interview takes 5-10 minutes to complete for each resident for whom we have consent/assent. | Data will be taken pre- and post-renovation (approximately 2 years later or whenever renovations are complete). The QUALID takes approximately 10 minutes to complete whereas DCM occurs over 2 days. | |
| Secondary | Changes in the Quality of Life of Residents: Dementia Care Mapping | Dementia Care Mapping (DCM) involves observing residents over several hours. The goal of this assessment is to collect in-depth data regarding resident's behaviours and use of space/time during a discrete time period. Mapping takes place using a designated instrument by a certified mapper, and in communal care and living spaces. One to twenty four different domains are tracked that can be said to account for a high level or a low level of well-being or quality of life. Observations of family members may also occur for those who have provided consent. Observational data will be entered into a computer program that provides profiles of residents' mood, engagement and well-being. This provides a useful index of the relative well-being or detriments that affect an individual in a given space and given specific relational and care activities. | Data will be taken pre- and post-renovation (approximately 2 years later or whenever renovations are complete). The QUALID takes approximately 10 minutes to complete whereas DCM occurs over 2 days. | |
| Secondary | Use and Maintenance of Space from Pre- to Post-renovation | Key staff informants will participate in a walk-through interview where the informant and investigator walk through the unit and discuss the physical space. This is a qualitative interview. | Perspectives taken pre- and post-renovation (approximately 2 years later or whenever renovations are complete). | |
| Secondary | Changes in Indoor Environment Measures: Dry Bulb Temperature | Measures will be taken of dry bulb temperature at pre- and post-renovations. Optimum comfort for sedentary work is between 20°C and 26°C, depending on the time of year and clothing worn. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Air Speed | Measures will be taken of air speed at pre- and post-renovations. For an all air systems, air velocity (speed) should be typically 20 fpm (0.1m/sec) to 40 fpm (.2 m/sec) to be experienced by the occupant. 40 fpm would be experienced in a laboratory environment whereas 15-20 fpm would be typical for an office space. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Relative Humidity | Measures will be taken of relative humidity at pre- and post-renovations. Indoor humidity level should be 30-50%. When outdoor temperature is below -10 degrees C, indoor relative humidity should be 30%. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Light Level | Measures will be taken of light level at pre- and post-renovations. Light level should be a minimum 322.92 lux of continuous lighting levels in all corridors and enclosed stairways, bedrooms, vestibules, washrooms, and tub and shower rooms. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Noise Level | Measures will be taken of noise level at pre- and post-renovations. Limit exposure to 85 decibels averaged over 8 hours, with a peak level of 140dB. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Air Quality - Volatile Organic Compounds (VOC) | Measures will be taken of air quality based on concentrations of VOC at pre- and post-renovations. Recommended levels:
Butadiene (1.7 µg/m3) Dichlorobenzene (60 µg/m3) Butoxyethanol 11000 µg/m3) Ethoxyethanol (70 µg/m3) Chloropropene (1 µg/m3) |
Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Air Quality - Carbon Dioxide (CO2) | Measures will be taken of air quality based on concentrations of CO2 at pre- and post-renovations. Exposure limits:
long-term exposure limit (24 hours): 11.5 mg/m3 (10 ppm) short-term exposure limit (1 hour): 28.6 mg/m3 (25 ppm) |
Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Air Quality - Formaldehyde | Measures will be taken of air quality based on concentrations of formaldehyde at pre- and post-renovations. Exposure limits:
long-term exposure limit for 8 hours: 50 µg/m3 (40 ppb) short-term exposure limit (1 hour): 123 µg/m3 (100 ppb) |
Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) | |
| Secondary | Changes in Indoor Environment Measures: Air Quality - Airborne Particulates | Measures will be taken of air quality based on concentrations of airborne particulates at pre- and post-renovations. | Data will be collected for prior to and after the renovations (approximately 2 years later or whenever renovations are complete) |
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