Table 3 Measurement instruments used to collect quantitative and qualitative data to inform the process evaluation

1a)

Sociodemographic information

Researcher about dyad

Screening

To assess characteristics of companion and participant (covariates of age, gender, living conditions influencing outcomes)

1b)

Medical history

Researcher about dyad

Screening

Dementia sub-type and medication may influence uptake and effectiveness of intervention (eliciting the type of memory impairment and the current medication)

1c)

HearCheck

PEEK acuity, visual field confrontation test

Researcher about PwD

Screening

To establish the baseline for ‘C’ and ‘O’ for intervention/optimisation of function (screening for severity of visual and hearing loss of participant)

1d)

MoCA

Researcher about PwD

Screening

To ascertain impact of sensory optimisation on cognitive ability as intermediate step (‘C’ and ‘M’) leading to improved QoL (assessing cognitive level of participant scale (score ≥ 10); also decides whether the participant is appropriate candidate for the study)

1e)

DEMQoL

Researcher about PwD

Baseline

The primary outcome of the behavioural change process, resulting from intermediate impacts (assessing quality of life of PwD by addressing all parts of the process evaluation: ´C´, ´O´, ´M´)

1f)

BADLs

Companion about PwD

Baseline

To ascertain impact of sensory optimisation on functional ability as intermediate step (‘C’ and ‘M’) leading to improved QoL (assessing functional ability of PwD)

1g)

VA LV-VFQ-20

Researcher about PwD and companion

Baseline

Improvement in sensory input affects ‘C’, ‘O’ and ‘M’, all impacting on intermediate outcomes leading to overall improvement in QoL (assessing for vision- and hearing-related functional ability)

1 h)

HHIE-25

Researcher about PwD and companion

Baseline

1i)

NPI-12

Researcher and companion about PwD

Baseline

To ascertain impact of sensory optimisation on neuropsychiatric function as intermediate step (‘C’, ‘O’ and ‘M’) leading to improved QoL (assessing behavioural and psychological symptoms like anxiety, agitation etc.)

1j)

RSS

Researcher about PwD (companion completes on its own)

Baseline, week 18, week 36

Improved dyadic relationship optimises ‘O’, thus leading to improved QoL (capturing current level of relationship satisfaction between the PwD and study companion, reduce feelings of loneliness)

1 k)

EQ-5D-5 L

Researcher about PwD and companion

Baseline

To measure uptake of health services, enhancing ‘O’ (assessing health resource utilisation and capturing the amount and type of support that is in place)

1 l)

RUD-Lite

Researcher and companion about PwD

Baseline, week 18, week 36

1 m)

PwD full visual and/or hearing assessment

By optometrist and/or audiologist about PwD

Following randomisation

To establish the baseline for ‘C’ and ‘O’ (assessing the degree of the PwD’s visual and/or hearing loss)

2)

Delivered devices record

By researcher/therapist about PwD

Following receipt of glasses and/or hearing aids

To ascertain the ‘dose’ of the intervention (capturing the number and type of corrective sensory devices prescribed by the optometrist and/or audiologist)

3a)

PwD diary (acceptability and tolerability of therapy)

By PwD about their own experiences

Throughout sensory intervention

To ascertain the utility of the ‘correction’ component of the intervention from the PwD’s perspective (capturing the PwD’s ratings on acceptability and tolerability of the SI and acceptability across five indices (helpfulness, fatigue, effort, understanding and motivation) as well as the PwD’s view about their corrective sensory devices—also informing ´C´)

3b)

PwD diary (acceptance of devices)

By PwD about their own experiences

Throughout sensory intervention

3c)

Companion diary (acceptability of therapy)

By companion about PwD’s experiences

Throughout sensory intervention

To ascertain the utility of the ‘correction’ component of the intervention from the companion’s perspective (capturing companions’ ratings on the PwD’s response to the session across five indices of therapy acceptability (interest, autonomy, motivation, emotional responses and mastery) recorded after each session)

3d)

Companion diary (adaptation to devices)

By companion about PwD’s experiences

Throughout sensory intervention

To ascertain uptake/adherence with the corrective devices; to assess level of inter-site variability (capturing companions’ ratings on the PwD’s adaptation to and management and use of the corrective sensory devices)

3e)

Companion diary (companion’s confidence)

By companion about their own experiences

Throughout sensory intervention

To capture the companion training component of the intervention; to assess level of inter-site variability (capturing companion’s confidence in supporting the PwD’s use of their corrective sensory devices)

4a)

SST logbook (visit record)

By therapist about SI visits

Throughout sensory intervention

To ascertain dose of the intervention; to assess level of inter-site variability by:

- Measuring the dose of the SI (number of sessions, duration of each session and frequency)

- Quantifying the PwD’s capability, opportunity and motivation to use their glasses/hearing aids

-Capture adherence to the protocol, i.e. which aspects of the SI were delivered by the SST

4b)

SST logbook (response to corrective devices)

By therapist about PwD

Throughout sensory intervention

4c)

SST logbook (delivered components record)

By therapist about SI visits

Throughout sensory intervention

4d)

Bangor Goal Setting Inventory

By therapist about PwD

End of sensory intervention

To measure little changes within ´M´ (capturing the number and type of goals set by the PwD, and their progress towards these during the SI—address support care needs)

4e)

Hearing aid skills and knowledge test and/or glasses/vision skills and knowledge test

By therapist about PwD

Following receipt of hearing aids/glasses and at end of sensory intervention

To enhance self-efficacy both in PwD and companion: ´C´ and ´O´ (capturing the change in the PwD and companion’s skills and knowledge in using their corrective sensory devices through receiving the SI)

4f)

GHABP

By audiologist and therapist about PwD

At audiology assessment and at end of sensory intervention

To ascertain improved dyadic communication outcomes: ´C´(capturing self-reported gains from hearing aid use)

5)

Dyadic experience of SI (interview)

By researcher about PwD and companion

Intervention end

To ascertain how the interviews with the dyads were experienced (reflecting upon the positive and negative experiences of intervention for the dyads, perceived benefits/short-comings, suggestions for improvement)

6)

Battery of outcome measures

By researcher about PwD

Baseline, week 18, week 36

The secondary outcome of the support intervention focusing on behavioural changes (assessing outcomes for participants and companions)

7a)

SST knowledge and skills checklist

By therapy supervisor about each therapist

Prior to and post-SST training

To assess level of inter-site variability as to the SST by:

- A 13-item self-rated questionnaire to identify existing knowledge and skills necessary for the SST role and training needs pre and post-SST training)

- Verifying that the SST has received training in the delivery of the SI components)

- Verify that the SST is competent to undertake the role

- Capturing the number, duration and essence of supervision provided by the senior SST

- Assessing positive and negative aspects of intervention, emerging adaptations, suggestions for improvement

7b)

SST training log

By therapy supervisor about each therapist

Prior to trial commencement

7c)

SST competency checklist

By therapy supervisor about each therapist

Prior to trial commencement

7d)

SST supervision log and reflective diary

By each therapist and therapy supervisor about themselves

Throughout trial intervention