The Frailty Reduction via Implementation of Exercise, Nutrition, and Deprescribing (FRIEND) Trial: Study Protocol and Recruitment Results
Abstract
:1. Introduction
1.1. Aim
1.2. Research Objectives
1.2.1. Primary Objectives
1.2.2. Secondary Objective
2. Methods
2.1. Study Design
2.2. Study Population
2.3. Eligibility Criteria
2.3.1. Aged Care Residents
2.3.2. Family Member/Informal Caregivers of Participating Residents
2.3.3. Staff Members
2.4. Recruitment
2.5. Sample Size
2.6. Screening Procedure
2.7. Interventions
2.7.1. Best Practice Frailty Interventions for Residents
Exercise Component of the FRIEND Intervention
Nutritional Component of the FRIEND Intervention
Medication Review Component of the FRIEND Intervention
- Ascertain indications of all drugs the resident was taking;
- Consider the overall risk of drug-induced harm (drug–drug interaction, drug–exercise/nutrition interactions);
- Assess each medication for its eligibility and whether it should be discontinued;
- Prioritise drug discontinuation;
- Monitor drug discontinuation regimens.
2.7.2. Educational Component of the FRIEND Intervention
Residents and Family Members/Informal Caregivers
Participating Staff Members
2.7.3. Rolling Implementation of Intervention Components
2.8. Post-Trial Care
2.9. Outcome Measures
2.9.1. Study Participant Data
2.9.2. Facility-Wide Audit Data
2.10. Analysis Plan and Dissemination Plan
3. Baseline Results
3.1. Recruitment
3.2. Baseline Demographics
Residents | ||
---|---|---|
Sample (n) | Mean (SD) or n | |
Age (years) | 29 | 88.6 (6.3) |
Sex (female/male), n | 21/8 | |
Body Mass Index (kgm−2) | 27 | 26.2 (4.4) |
Calf circumference (cm) | 23 | 34.1 (3.0) |
Time since admission to facility (months) | 29 (4–182) * | |
Prescribed medications and polypharmacy Regular PRN Total prescribed Community definition (≥5), n Aged care definition (≥9), n Hyper-polypharmacy (≥15), n | 29 | 10.7 (4.0) 4.8 (3.5) 15.5 (5.9) 24 21 15 |
Frailty FRAIL-NH (/14) Fried’s Frailty Phenotype (/5) | 29 23 | 6.3 (2.4) 3.3 (1.1) |
Cognition MoCA score (/30) Affect GDS-15 (/15) Significant depressive symptoms (>5/15, n) | 29 26 | 13.8 (6.8) 4.3 (3.9) 10 |
Physical function and capacity SPPB (/12) 6MWT distance (m) | 26 21 | 4.9 (3.1) 222.2 (104.4) |
Caregivers | ||
Sample (n) | n | |
Sex (female/male), n | 30 | 22/8 |
Relationship to resident Spouse Daughter/daughter-in-law Son/son-in-law Sibling/sibling-in-law Close friend/acquaintance | 0 18 8 2 2 | |
Staff | ||
Sample (n) | Mean (SD) or n | |
Sex (female/male), n | 19 | 17/2 |
Role Frontline Managerial Senior executive/leadership | 19 | 12 5 2 |
Time working at facility (months) | 17 | 72 (0–210) * |
Time working in aged care (months) | 72 (1–408) * |
4. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Outcome | Question/Scope | Measure | Timepoint * |
---|---|---|---|
Implementation | |||
Acceptability | Experience of integrating the intervention | Semi-structured interviews with staff members, residents, and family members/informal caregivers. | M12 |
Adoption | Satisfaction with amount, content, and format of training provided | Number of staff, residents, and family members/informal caregivers who undertake the educational training modules. | M0–M12 |
Questionnaire on experience of training and applicability of the skills learned—administered to staff, residents, and family members/informal caregivers. | M12 | ||
Practice change via the Implementation Behaviour Survey administered to staff members. | M12 | ||
Audit of intervention components delivered and resident adherence to the intervention components evaluated using self-designed intervention logs. | M0–M12 | ||
Influences on uptake, integration, and routinisation (roles, relations, context, value systems, barriers/enablers) | Focus groups with managerial and senior representatives of TGSH regarding evaluation of system and process changes to embed the intervention within the organisation’s policies and procedures. | M0, M12 | |
Monthly implementation team meeting notes. | |||
Semi-structured interviews with managerial staff and healthcare staff. | M12 | ||
Knowledge transfer and fidelity | Fidelity to key intervention features; adherence and outcome indictors | Fidelity to key intervention features evaluated via fidelity checks with research and staff members involved in the delivery of the intervention using self-designed fidelity checklists. | M0–M12 |
Pre- and post-training knowledge acquisition quiz administered to staff, residents, and informal caregivers. | M0, M12 | ||
Focus group discussions with consumer and consumer representatives, healthcare professionals, and stakeholders to provide feedback on the content of the FRIEND trial website which will be used for ongoing refinement. | M12 | ||
Cost | Cost of service implementation | Calculation of the cost involved with delivering the FRIEND intervention components (staff time, resources required). | M12 |
Preliminary effectiveness | |||
Frailty status | Changes in clinical outcome measures of residents | Frail Nursing Home scale (FRAIL-NH scale). Scored out of 14, with a higher score indicating greater level of frailty [36]. | M0, M6, and M12 |
Frailty (Fried phenotype) | Derived from existing measures. Weakness (chair stand from SPPB), slowness (gait speed from SPPB), shrinkage (weight change from institutional data), fatigue (Q13 GDS-15), sedentariness (not meeting weekly exercise guidelines of 150/mins of at least moderate physical activity each week). Scored out of 5, with a score of 1–2 indicating pre-frailty and 3–5 indicating frailty [4]. | ||
Nutritional status | Mini-nutritional Assessment (MNA)—including weight, height, mid-arm, and mid-calf circumferences. A score of 24–30/30 indicates normal nutrition, 17 to 23.5 indicates at risk of malnutrition, and <17 points indicates malnourished state [37]. | M0, M6, and M12 | |
Medication count and use of potentially inappropriate medications (PIMs) | Medication audit. | ||
Functional mobility and capacity | Short Physical Performance Battery (SPPB). Scored out of 12, with scores < 10 indicating greater risk of disability and adverse events [38]. Six-minute walk test (6MWT). Higher distance covered in a six-minute period indicates better function [39]. | M0, M6, and M12 | |
Maximal dynamic muscle strength | One-repetition maximum (1RM) strength on leg press and knee extension machines ** | M0, M6, and M12 | |
Quality of life | Quality of Life–Alzheimer’s Disease scale (QoL-AD scale). Scored out of 52, with a higher score indicating better quality of life [40]. | M0, M6, and M12 | |
Cognitive function | Montreal Cognitive Assessment (MoCA). Scored out of 30, with a higher score indicating better cognitive function and scores ≤ 26/30 indicating cognitive impairment [41]. | M0, M6, and M12 | |
Depressive symptoms | Geriatric Depression Scale—Short Form 15 Item (GDS-15). A higher score out of 15 indicates greater depressive symptoms, with a score > 5/15 indicating significant depressive symptoms [42]. | M0, M6, and M12 | |
Health status | Past medical history | Past medical diagnosis and symptoms (physical, mental, or emotional), past treatments, medications, past falls. | M0 |
Ongoing health status | New medical diagnosis, new (or change) in symptoms, new (or change) in medications, falls, visits to healthcare practitioners. Gathered using a weekly health check questionnaire | Weekly | |
Clinical trial requirements | |||
Adverse events | All adverse events | All adverse events related and not related to the intervention. Gathered using weekly health status check and reporting of events throughout the study period. | M0–M12 |
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Share and Cite
Inskip, M.; Almendrales Rangel, C.; Njoku, C.M.; Barnett, F.; Shih, I.; O’Neill, L.; Fiatarone Singh, M.A.; Valenzuela, T. The Frailty Reduction via Implementation of Exercise, Nutrition, and Deprescribing (FRIEND) Trial: Study Protocol and Recruitment Results. Methods Protoc. 2024, 7, 26. https://doi.org/10.3390/mps7020026
Inskip M, Almendrales Rangel C, Njoku CM, Barnett F, Shih I, O’Neill L, Fiatarone Singh MA, Valenzuela T. The Frailty Reduction via Implementation of Exercise, Nutrition, and Deprescribing (FRIEND) Trial: Study Protocol and Recruitment Results. Methods and Protocols. 2024; 7(2):26. https://doi.org/10.3390/mps7020026
Chicago/Turabian StyleInskip, Michael, Carolina Almendrales Rangel, Chidiamara Maria Njoku, Fiona Barnett, Isabel Shih, Leonie O’Neill, Maria A. Fiatarone Singh, and Trinidad Valenzuela. 2024. "The Frailty Reduction via Implementation of Exercise, Nutrition, and Deprescribing (FRIEND) Trial: Study Protocol and Recruitment Results" Methods and Protocols 7, no. 2: 26. https://doi.org/10.3390/mps7020026