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

From: A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial

Measurement toolData captured by whom? About whom/what?Timing of data captureProcess evaluation (Capability ´C´, Opportunity ´O´, Motivation ´M´) and measurement instruments (details)
1a)Sociodemographic informationResearcher about dyadScreeningTo assess characteristics of companion and participant (covariates of age, gender, living conditions influencing outcomes)
1b)Medical historyResearcher about dyadScreeningDementia 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 PwDScreeningTo establish the baseline for ‘C’ and ‘O’ for intervention/optimisation of function (screening for severity of visual and hearing loss of participant)
1d)MoCAResearcher about PwDScreeningTo 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)DEMQoLResearcher about PwDBaselineThe 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)BADLsCompanion about PwDBaselineTo 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-20Researcher about PwD and companionBaselineImprovement 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-25Researcher about PwD and companionBaseline
1i)NPI-12Researcher and companion about PwDBaselineTo 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)RSSResearcher about PwD (companion completes on its own)Baseline, week 18, week 36Improved 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 LResearcher about PwD and companionBaselineTo 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-LiteResearcher and companion about PwDBaseline, week 18, week 36
1 m)PwD full visual and/or hearing assessmentBy optometrist and/or audiologist about PwDFollowing randomisationTo establish the baseline for ‘C’ and ‘O’ (assessing the degree of the PwD’s visual and/or hearing loss)
2)Delivered devices recordBy researcher/therapist about PwDFollowing receipt of glasses and/or hearing aidsTo 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 experiencesThroughout sensory interventionTo 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 experiencesThroughout sensory intervention
3c)Companion diary (acceptability of therapy)By companion about PwD’s experiencesThroughout sensory interventionTo 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 experiencesThroughout sensory interventionTo 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 experiencesThroughout sensory interventionTo 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 visitsThroughout sensory interventionTo 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 PwDThroughout sensory intervention
4c)SST logbook (delivered components record)By therapist about SI visitsThroughout sensory intervention
4d)Bangor Goal Setting InventoryBy therapist about PwDEnd of sensory interventionTo 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 testBy therapist about PwDFollowing receipt of hearing aids/glasses and at end of sensory interventionTo 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)GHABPBy audiologist and therapist about PwDAt audiology assessment and at end of sensory interventionTo 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 companionIntervention endTo 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 measuresBy researcher about PwDBaseline, week 18, week 36The secondary outcome of the support intervention focusing on behavioural changes (assessing outcomes for participants and companions)
7a)SST knowledge and skills checklistBy therapy supervisor about each therapistPrior to and post-SST trainingTo 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 logBy therapy supervisor about each therapistPrior to trial commencement
7c)SST competency checklistBy therapy supervisor about each therapistPrior to trial commencement
7d)SST supervision log and reflective diaryBy each therapist and therapy supervisor about themselvesThroughout trial intervention
  1. MoCA Montreal Cognitive Assessment [30], DEMQoL Dementia Quality of Life [24], BADLs Bristol Activities of Daily Living Scale [22], VA LV-VFQ-20 Veterans Affairs Low vision Visual Functioning Questionnaire-20 items [34], HHIE-25 Hearing Handicap Inventory for the Elderly-25 items [28], NPI-12 Neuropsychiatric Inventory-12 items [31], RSS Relationship Satisfaction Scale [32], EQ-5D-5 L 5-level EuroQol 5-dimension [47], RUD-Lite Resource Utilization in Dementia-Lite [48], GHABP Glasgow Hearing Aid Benefit Profile [49]