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

Abstract

Background: Loneliness 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.

Methods: Participants 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.

Results: We 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).

Conclusions: Recruitment 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 registration: ISRCTN28645428.

Figure 1

Flow of participants through the study. ^aOne withdrawn by Chief Investigator due to protocol violation relating to eligibility; two withdrew consent shortly after allocation (one unhappy with involvement of service provider; one felt the study was not for them); five withdrew consent at the point of arranging 6 month follow-up (one due to ill health; one no longer unhappy so did not want to take part; one unhappy with the intervention - at this point they had not received any calls; one other reason - unhappy with being left uninformed about lack of intervention; one due to personal or family issues); one not contactable (minimum of six telephone attempts and reminder letter sent). ^bOne withdrew consent at the point of arranging 6 month follow-up (unhappy with allocated study arm); one not contactable (line dead, letter and email reminder sent); one on 4 week holiday; two refused (one felt no different so did not want to answer the same questions again; one was too ill). ^cTwo participants no longer wanted intervention (one was too busy; one thought intervention was not for them) and one participant did not give any reason for intervention withdrawal. ^dAssigned to intervention group 4 but the volunteer dropped out before intervention delivery. ^eOne withdrew consent at the point of arranging 6 months follow-up (unhappy with study arm allocation); one not contactable (no dial tone, letter and email reminder sent); one on four week holiday; two refused (one felt no different so did not want to answer the same questions again; one felt too ill). ^fTwo no longer wanted intervention (one was too busy; one thought intervention was not for them); one did not give any reason for intervention withdrawal. ^gAssigned to intervention group 4 but intervention not delivered as volunteer dropped out. ITT, intention-to-treat.

Figure 2

Mean Short Form (36) (SF-36) Mental Health Dimension scores over time by randomised group.

Figure 3

Forest plot of sensitivity analysis of mean difference in Short Form (36) Health Instrument (SF-36) mental health outcome between groups. LOCF, last observation carried forward; PMM, predictive mean matching.