‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

Abstract

BackgroundLoneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention.MethodsParticipants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation.ResultsWe informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16).ConclusionsRecruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers.Trial registrationISRCTN28645428.

Effectiveness of befriending interventions: a systematic review and meta-analysis

“…All studies identified a primary outcome which included measures across depression, 14–16 19 23 25 social support, 17 18 27 social network, 26 mental well-being, 20 quality of life 21 24 and social functioning 22 ( table 2 ). There were eight patient-reported outcomes, five clinician-reported outcomes and one study that included both patient and clinician-reported outcomes.…”

Maintaining older brain functionality: A targeted review

“…These type of programs designed specifically for older adults show positive effects on sense of wellbeing and social engagement (Ballesteros et al, 2014b;Pao, 2014). Technology-based studies such as teleconferencing were the channel used by trained volunteers with urban elders recruited from primary care practices (Mountain et al, 2014). This pilot RCT study aimed to recruit individuals aged 74+ with a good cognitive function and living independently in order to establish whether a home-based intervention set up on telephone communication delivered through trained volunteers could improve or successfully maintain mental wellbeing of older people who were vulnerable and hard to reach.…”

Recommendations for the analysis of individually randomised controlled trials with clustering in one arm – a case of continuous outcomes

“…We compared 10 models using four example case studies from iRCTs with clustering in one arm: specialist clinics for the treatment of venous leg ulcers [15], acupuncture for low back pain [7], cost-effectiveness of community postnatal support workers (CPSW) [16], and Putting Life in Years (PLINY) [17]. These studies were selected from our portfolio of studies as trial statisticians that had clustering in one arm only.…”