Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial

Study design

The study is funded by the National Institute of Health Research (NIHR) as part of
a Doctoral Research Fellowship award. Ethical approval was received from the Humber
Bridge Research Ethics Committee (REC), later transferred to South Yorkshire REC (reference:
13/YH/0319).

The trial is a rater-blinded controlled trial using a concealed computer-generated
random allocation sequence. Recruitment will run between April 2014 and January 2015.
Outcomes are assessed at 6 months by an independent research nurse blinded to the
allocation sequence. Qualitative interviews and observations will form part of a process
evaluation to explore acceptability and assess intervention fidelity.

Recruitment and randomisation

Sixty adults aged 65 years and over will be recruited from primary care practices
across Bristol and the surrounding area. As this is a pilot study designed to explore
feasibility, it will not be powered for a primary outcome. The sample size was selected
to ensure sufficient numbers were available in both arms to provide useful data on
process evaluation measures and variability in outcome measures. This sample size
is consistent with other pilot studies of physical activity interventions 19],20]. The study will be open to both male and female participants; full eligibility criteria
are listed in Table 1.

Table 1. Eligibility criteria

Up to six primary care practices will be selected from wards of differing deprivation
level. We aim to evaluate alternative methods of recruitment in the study: conventional
postal invitation and opportunistic recruitment by a researcher sitting in the waiting
room. The effectiveness, acceptability, and feasibility of each recruitment method
will be evaluated.

For practices using the postal invitation approach, general practitioners (GPs) will
randomly select 375 patients from their list of eligible patients, excluding those
they know to be ineligible, or those whom it would be inappropriate to approach (for
example, those suffering from a recent bereavement). An invitation letter with a study
information sheet will be sent to these patients. The invitation letter will contain
a reply slip for interested individuals to make contact with the study team. Non-responders
will be sent one reminder invitation. Interested individuals recruited through postal
interviews will undergo telephone screening initially; this will enable exclusion
of individuals who are already meeting the minimum recommended levels of physical
activity, or who are unable to walk for a quarter of a mile. Patients eligible at
this stage are invited to a clinical screening clinic.

In practices using opportunistic waiting room recruitment, older patients attending
the practice for appointments will be approached by a researcher prior to their appointment.
The researcher will check the basic eligibility criteria at this stage, and those
interested and potentially eligible will be invited to a clinical screening appointment.

At the clinical screening appointment patients will be objectively assessed as ‘non-disabled’
using a timed 4-metre walk. This assessment is practical and highly predictive (90%)
of successfully completing the well-established 400-metre walk test within 15 minutes
21]. Individuals will also be assessed as ‘at risk of disability’ using the SPPB. Scores
of less than 10 out of 12 on the SPPB represent up to a 5-fold increased risk of new-onset
disability within 4 years 16]; this will be the threshold for inclusion in the PACE study and is consistent with
the threshold used in other physical activity intervention trials 14].

Before the clinical screening appointment, potentially eligible patients will be sent
a questionnaire in the post for prior completion, containing self-report measures
of physical activity 22], motivation for physical activity, and mood 23]. At the clinical screening appointment patients will be asked about specific medical
conditions that may mean physical activity is contraindicated, such as unstable angina
or critical heart valve disease, based upon the eligibility criteria. Should the study
investigator have concerns about the suitability of a patient for the study then these
concerns may be discussed with the patient’s GP before enrolment.

Eligible patients will provide informed written consent and will be enrolled in the
study immediately following the clinical screening appointment. Further baseline measures
will be completed at this time (Table 2). Participants will also be provided with an ActiGraph GT1M accelerometer to be worn
on the hip for 7 days and a journey log to document trips made during this period.

Table 2. Baseline and follow-up measures

Randomisation will use a sequence minimising on age, gender, and GP practice. This
will be computer-generated by the Bristol Randomised Trials Collaboration, a UK Clinical
Research Collaboration (UKCRC)-registered clinical trials unit. The randomisation
ratio will be 2:1 favouring the intervention arm (40 participants) over the control
arm (20 participants). Once the participant has been allocated to either the intervention
or control arm, this assignment will be made available to the researcher and participant:
it is not possible to blind participants to the treatment allocation. Participants’
GPs are contacted following each enrolment and are briefed about the exclusion criteria,
to ensure no patient is enrolled inappropriately.

Treatment arms

Participants randomised to the intervention arm will be contacted by a trained PAF
facilitator. It is anticipated that if cost-effective, the PAF intervention could
be delivered by nurses or healthcare workers in community settings and so a background
in physical activity or healthcare is a desirable, but not essential criteria for
appointment. For the pilot trial 2 PAFs will be appointed and will receive a 3-day
training course covering the theoretical background to the intervention, the principle
behaviour change strategies relevant to the intervention, and an introduction to communication
using motivational interviewing techniques. A comprehensive manual will be provided,
and training sessions will be evaluated by observation, audio recording and transcription,
and PAF feedback. PAF facilitators will have access to regular and frequent supervision
and support throughout the trial.

Each intervention participant will receive an initial face-to-face PAF session, and
after this participants will be offered up to two further face-to-face sessions, and
up to nine telephone support sessions. These sessions are not at fixed intervals but
are flexibly tailored to suit the participant and their progress. All intervention
participants are offered the opportunity to involve a spouse, friend or close social
partner in the sessions, or in supporting them to increase their activity levels.
Worksheets designed to assist with behaviour change techniques such as goal setting
and feedback are available for participants to use if they choose. PAF facilitators
will keep detailed logs of each session and will reflect on how they are addressing
the theoretical components of the intervention.

Participants allocated to the control arm will receive a booklet on healthy ageing,
containing health promotion messages such as healthy diet, physical activity, and
falls prevention. This is produced by Age UK, is publicly available and is, therefore,
compatible with ‘usual care’.

Measures and analysis

The main quantitative outcomes will be recruitment, adherence, and retention rates,
in order to inform the design of a future full-scale trial. All participants will
be followed-up 6 months after enrolment, and the baseline measures undertaken at month
0 will be repeated by a trained practice nurse or healthcare assistant who is blinded
to the treatment allocation. Simple descriptive statistics will be used to describe
the distribution and baseline variability of all outcomes of interest, and effect
sizes may be calculated to assess for evidence of promise, whilst accepting that the
study will not be powered to provide strong evidence against the null hypothesis.
The variability of the parameters will contribute to a sample size calculation for
the full-scale trial.

In the full-scale trial the primary outcomes will be the ability to complete the 4-metre
walking test and the SPPB. Secondary outcomes will include physical activity (measured
objectively and by self-report); body mass index (BMI); grip strength; and measures
using the following tools: Lawton’s self-reported ADL 24]; Geriatric Depression Scale 23]; Montreal Cognitive Assessment (MoCA) 25]; and the Social Support Questionnaire (SSQ) 26]. Costs of the intervention will be documented, and healthcare use estimated from
primary care records. The cost-effectiveness of the intervention may be estimated
using data from the European Quality of Life 5 Dimensions (EQ-5D) 27] and ICECAP-O 28] quality of life tools. Full details of the measures collected in the pilot trial
are shown in Table 2.

Adverse events may be expected in physical activity trials. Participants in both study
arms will be asked about adverse events regularly; all adverse events will be reviewed
and recorded. Serious adverse events will be reported to the sponsor and an independent
clinical geriatrician, who will be responsible for discussing any concerns with the
sponsor and advising the study team accordingly.

Process evaluation

In order to evaluate whether the intervention operates as anticipated, process measures
of physical activity expectations, motivations, and psychological needs satisfaction
will be collected. These data will be supported by data gathered from qualitative
interviews to assess whether the intervention is functioning at the levels expected.
PAF sessions will be audio-recorded where possible and observed, allowing assessment
of fidelity of the intervention. A purposefully-selected sample of participants will
be asked to participate in a semi-structured interview. The interview will explore
experiences of the intervention and trial, and attitudes and beliefs about physical
activity. In addition, semi-structured interviews will be held with GPs, nurses, and
primary care staff involved in the PACE study, and with the PAF facilitators, to explore
their attitudes to the intervention and their experiences of the pilot trial. Interviews
will be audio recorded, transcribed, and analysed using the Framework approach 29].

Trial Advisory Committee

As this is a pilot study, no formal data monitoring committee will be convened. However
the study has a Trial Advisory Committee (TAC), comprising an academic general practitioner,
clinical geriatrician, and academics experienced in trial design, physical activity
interventions in older adults, and statistics. The TAC provides advice on study design,
adverse events, and data analysis.