MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty - protocol for a double-blind, randomised controlled proof-of-concept trial.

INTRODUCTION: Skeletal muscle dysfunction is central to both sarcopenia and physical frailty, which are associated with a wide range of adverse outcomes including falls and fractures, longer hospital stays, dependency and the need for care. Resistance training may prevent and treat sarcopenia and physical frailty, but not everyone can or wants to exercise. Finding alternatives is critical to alleviate the burden of adverse outcomes associated with sarcopenia and physical frailty. This trial will provide proof-of-concept evidence as to whether metformin can improve physical performance in older people with sarcopenia and physical prefrailty or frailty. METHODS AND ANALYSIS: MET-PREVENT is a parallel group, double-blind, placebo-controlled proof-of-concept trial. Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. The recruitment target is 80 participants from two secondary care hospitals in Newcastle and Gateshead, UK. Local primary care practices will act as participant identification centres. Randomisation will be performed using a web-based minimisation system with a random element, balancing on sex and baseline walk speed. Participants will be followed up for 4 months post-randomisation, with outcomes collected at baseline and 4 months. The primary outcome measure is the four metre walk speed at the 4-month follow-up visit. ETHICS AND DISSEMINATION: The trial has been approved by the Liverpool NHS Research Ethics Committee (20/NW/0470), the Medicines and Healthcare Regulatory Authority (EudraCT 2020-004023-16) and the UK Health Research Authority (IRAS 275219). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community. TRIAL REGISTRATION NUMBER: ISRCTN29932357.

Can trained volunteers improve the mealtime care of older hospital patients? An implementation study in one English hospital.

OBJECTIVE: Multinational studies report undernutrition among 39% older inpatients; importantly, malnutrition risk may further increase while in hospital. Contributory factors include insufficient mealtime assistance from time-pressured hospital staff. A pilot study showed trained volunteers could safely improve mealtime care. This study evaluates the wider implementation of a mealtime assistance programme. DESIGN: Mixed methods prospective quasi-experimental study. SETTING: Nine wards across Medicine for Older People (MOP), Acute Medical Unit, Orthopaedics and Adult Medicine departments in one English hospital. PARTICIPANTS: Patients, volunteers, ward staff. INTERVENTION: Volunteers trained to help patients aged ≥70 years at weekday lunchtime and evening meals. MAIN OUTCOME MEASURES: The number of volunteers recruited, trained and their activity was recorded. Barriers and enablers to the intervention were explored through interviews and focus groups with patients, ward staff and volunteers. The total cost of the programme was evaluated. RESULTS: 65 volunteers (52 female) helped at 846 meals (median eight/volunteer, range 2-109). The mix of ages (17-77 years) and employment status enabled lunch and evening mealtimes to be covered. Feeding patients was the most common activity volunteers performed, comprising 56% of volunteer interactions on MOP and 34%-35% in other departments. Patients and nurses universally valued the volunteers, who were skilled at encouraging reluctant eaters. Training was seen as essential by volunteers, patients and staff. The volunteers released potential costs of clinical time equivalent to a saving of £27.04/patient/day of healthcare assistant time or £45.04 of newly qualified nurse time above their training costs during the study. CONCLUSIONS: Patients in all departments had a high level of need for mealtime assistance. Trained volunteers were highly valued by patients and staff. The programme was cost-saving releasing valuable nursing time. TRIAL REGISTRATION NUMBER: NCT02229019; Pre-results.