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Trial registered on ANZCTR

Registration number

ACTRN12622000926730p

Ethics application status

Submitted, not yet approved

Date submitted

23/06/2022

Date registered

29/06/2022

Date last updated

29/06/2022

Date data sharing statement initially provided

29/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project: The FRIEND Project

Scientific title

Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project: The FRIEND Project - Pilot implementation study in older adults with mild cognitive impairment or dementia

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

FRIEND

Linked study record

Health condition

Health condition(s) or problem(s) studied:

frailty

cognitive impairment

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study involves the delivery of a multicomponent intervention which aims to reduce frailty in residents of aged care living with Mild Cognitive Impairment or Dementia.

FRIEND intervention components:
Individualised treatment plan for the reduction of frailty:
As part of the study, the research team including the study geriatrician, dietitian, exercise physiologist, and pharmacist will work together with the Clinical Nurse Manager and relevant staff members at TGSH, including the resident’s general practitioner (GP), to design individualised treatment plans for the residents that aim to reduce frailty via the implementation of an exercise, nutritional support and medication review intervention.

1. Exercise component of the FRIEND intervention:
Targeted residents will attend two strength and balance exercise training session per week. Sessions will be delivered in a purpose-built gym at TGSH and supervised by an Accredited Exercise Physiologist with a ratio of 1:1 to 1:3 depending on level of cognition and function. Session duration will be approximately 60 minutes. Specific resistance exercises critical for mobility and function will include leg press, knee extension, hip abduction, triceps, seated row, and chest press. Additional balance exercises will also be prescribed which include variations of static standing positions (tandem, semi-tandem) and dynamic balance (tandem walking within parallel bars). Intensity will be monitored via participant and assessor-rated ratings of perceived exertion (RPE) and will increase over the first 2 weeks to about 80% of peak capacity, and continuous progression will ensure intensity remains high throughout the intervention period.

2. Nutritional component of the FRIEND intervention:
Targeted residents will undergo a detailed assessment of their nutritional status and receive individualised nutritional support. This assessment will involve the completion (with assistance if necessary) of the Mini-nutritional assessment, along with a review of dietary intake and practices by liaising with facility food preparation staff and logs. The nutritional support includes the removal of unnecessary or potentially harmful dietary restrictions that may increase the risk of unintentional weight loss or increase the risk of malnutrition. The research team (including an nutritionist) will review the food/nutrient-drug interactions and exercise-diet interactions and advise the GP when possible, on the potential deprescription or dose reduction of any medication known to cause sedation, constipation, nausea, vomiting, anorexia, and/or diarrhoea. Supplementation of vitamin D will also be included in the nutrition support were indicated after assessment by the participant’s treating GP. Toincrease protein intake and enhance skeletal muscle synthesis a high protein snack will be provided after the exercise sessions and potentially at other times if needed. Nutritional recommendations will be made to the staff and family of residents with malnutrition to increase nutrient density and improve nutritional status. To increase appetite, when possible, exercise will be performed 1 hour prior to a meal to stimulate appetite, and/or walking for at least 5-10 minutes before meals when possible will be encouraged. Enhancement of the aesthetic aspects of food preparation and service and increased mealtime socialisation will be used to promote dietary intake. All of these changes will occur through collaboration with the facility and food preparation staff, who will implement these changes in practice with the consent of the individual.

3. Medication review: A complete drug audit will be carried out at baseline and monthly intervals. This information will be ascertained by reviewing facility records, liaising with the participant's medical team where necessary for further information, and also through in-person interviewing and assessing the participant (the latter to ascertain symptoms, goals, etc.). Established algorithms will be used to identify excess dosages, drugs without sufficient indication, and potentially inappropriate medications (based on BEERS list, STOPP protocols, anticholinergic burden, etc.). GPs will be sent a summary of recommendations based on these audits, including rationale and suggestions for deprescribing strategies. Particular emphasis will be placed on drugs with adverse effects on cognition, appetite, and mobility. Continuous monitoring for any adverse effects of discontinued or reduced dosages of medications will be undertaken by nursing staff and reported to GPs if necessary. The in-person interview will take place as part of the initial assessment and be no longer than 30 minutes at baseline for each resident participant, with case conferences held each month with the care team and study investigators to review progress.

4. Educational component of the FRIEND intervention:
Educational modules for residents and families (face-to-face), as well as pharmacy, nursing, GPs, and other relevant staff (online modules) will be delivered to educate on the role that exercise, nutrition and deprescribing has on reducing frailty and improving resident’s overall health. The education modules will be developed specifically for this study to build a comprehensive understanding of best-practice frailty intervention in aged care.

The educational modules for staff will include a general module (completed by all), followed by more specific and detailed modules on nutrition, exercise, and medication optimisation respectively, which will be assigned based on the role of the worker in relation to the participants (i.e. a chef will complete the general module, as well as the nutrition module. Conversely a nurse will complete the general module, plus the three specific modules due to their holistic role with the participants). Modules will consist of recorded lecture content (screen of presentation + talking head) specifically developed and adapted for the target audience presented in discrete chunks to improve engagement. Accompanying this lecture content will be instructional videos (when appropriate, such as 'how to' for performing various exercises), simple fact sheets summarising content, and a more comprehensive procedural document (for staff performing the various aspects of the intervention). All of these content will be accessed via a dedicated, encrypted website which securely links to the Redcap database. The general module is expected to take around an hour, while each specific module around 2-3 hours. A knowledge quiz will be completed prior to undertaking the modules, immediately after taking the modules, and then at the completion of the 6-month intervention.

Caregivers participants will also complete quizzes (adapted for lay audience) pre and post module delivery, and after 6 months, however will only complete a general module which has specifically adapted for a lay audience. This module will last 1-2 hours.

Resident participants will receive a simplified knowledge quiz before and after the delivery of a face-to-face resident talk delivered by the study intervention team lasting for 30-60mins.

All of the education modules will take place at baseline prior to the commencement of the 6-month nutrition, exercise and deprescribing intervention over a two week period.

Adherence and fidelity to both the educational modules and intervention components will be monitored via online completion of activities (education modules), and via routine data entry throughout the 6-month evaluation period (clinical case notes, dosage reports, redcap data entry, monthly case conference information).

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

No Control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary Effectiveness outcome: The FRAIL-NH scale for frailty

Timepoint [1]

Baseline and 6-months after enrolment

Secondary outcome [1]

Implementation: Acceptability (measured via Semi-structured interviews with staff members, residents, and family members/ informal caregivers)

Timepoint [1]

6-months after enrolment (post intervention)

Secondary outcome [2]

Implementation: Adoption (measured via Number of staff, residents and family members/ informal caregivers who undertake the education al training modules). Data collected via submission from website to redcap and website login data.

Timepoint [2]

Baseline and 6 months after enrolment (post-intervention)

Secondary outcome [3]

Implementation; Adoption (measured via questionnaire designed for study on experience of training and applicability of the skills learned – Administered to staff, residents, and family members/ informal caregivers.)

Timepoint [3]

After completion of educational training modules at baseline after enrolment

Secondary outcome [4]

Implementation: Adoption (Measured through Practice change via the Implementation Behaviour Survey and Alberta Context Tool Survey– Administered to staff members)

Timepoint [4]

6-months after enrolment (post-intervention)

Secondary outcome [5]

Implementation: Adoption (Measured via Audit of intervention components delivered and resident adherence to the intervention components evaluated using self-designed intervention logs)

Timepoint [5]

Monthly, from baseline through to 6-months after enrolment

Secondary outcome [6]

Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Focus groups with managerial and senior representatives of TGSH

Timepoint [6]

Planning phase (pre-implementation before baseline enrolment) and Evaluation phase (post-implementation at 6-months after enrolment)

Secondary outcome [7]

Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Monthly implementation team meeting notes)

Timepoint [7]

Monthly, from baseline through to 6-months after enrolment

Secondary outcome [8]

Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Semi-structured interviews with managerial staff and health care staff

Timepoint [8]

6-months after enrolment (post-intervention)

Secondary outcome [9]

Implementation: Fidelity - measured via fidelity checks with research and staff members involved in the delivery of the intervention using self-designed fidelity checklist

Timepoint [9]

Monthly, from baseline through to 6-months after enrolment

Secondary outcome [10]

Implementation: Knowledge Transfer - measured via Pre- and post-training knowledge acquisition quiz administered to staff, residents, and informal caregivers

Timepoint [10]

Prior to delivery of modules at baseline enrolment, immediately after module delivery at baseline, and at 6-months after enrolment (post-intervention)

Secondary outcome [11]

Implementation: Fidelity - measured via Focus group discussions with consumer and consumer representatives, health care professionals and stakeholders to provide feedback on the content of the FRIEND project website which will be used for ongoing refinement

Timepoint [11]

6-months after enrolment (post-intervention)

Secondary outcome [12]

Implementation: Cost of service implementation (Calculation of the cost involved with delivering the FRIEND intervention components (staff time, resources required). Data on salary will be collected from position descriptions and salary gradings for involved staff and an audit of the hours each staff member is involved in direct facilitation of the study components. Informal care provided by volunteers and caregivers will be calculated via audit of study logs and calculated based upon award rates for aged care carer position.

Timepoint [12]

Monthly, from baseline through to 6-months after enrolment

Secondary outcome [13]

Nutritional Status measured via Mini Nutritional Assessments (MNA) using participants self-report and extracting meal data from food preparation software. Measurements including weight (calibrated chair scale), height (knee heigh formula using tape measure), mid-arm and calf circumferences (by tape measure) will be taken by study investigators from baseline and 6-month after enrolment time points.

Timepoint [13]

All measurements - at baseline and at 6-months after enrolment (post-intervention).
Weight - Monthly, from baseline through to 6-months after enrolment (post-intervention)

Secondary outcome [14]

Medication audit [Medication count and use of potentially inappropriate medications (PIMs)] extracted from data-linkage to medical records in the facility.

Timepoint [14]

Monthly, from baseline through to 6-months after enrolment (post-intervention)

Secondary outcome [15]

Functional mobility - Six-minute Walk Test (6MWT)

Timepoint [15]

baseline and at 6-months after enrolment (post-intervention)

Secondary outcome [16]

Functional Mobility - Short Physical Performance Battery (SPPB)

Timepoint [16]

baseline and at 6-months after enrolment (post-intervention)

Secondary outcome [17]

Maximal dynamic muscle strength - One-Repetition Maximum - Leg press

Timepoint [17]