Background
Methods/design
Planning the process evaluation
Working with intervention developers and implementers
Overlap of the process and outcomes and cost-effectiveness evaluations
Description of the intervention
Causal assumptions about how change will be produced
Theoretical COM-B domain | Component of the sensory intervention | Behaviour change (B) due to the intervention | Immediate impact of the behaviour change (secondary outcomes of interest) | Intermediate impact of the behaviour change (secondary outcomes of interest) | Primary outcome of interest |
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Capability (C) (the individual’s psychological and physical capacity to engage in the activity concerned) | Correct visual / auditory impairment | • Hear and see better (HHIE-25;VA-LVVFQ-20) • Uptake and adherence improves (HASK) • Greater understanding /insight of impairments • Dyadic interaction improves (RSS) • Enhanced cognitive stimulation | • Enhanced cognitive functioning (MoCA) • Reduced neuropsychiatric symptoms (NPI-12) • Less loneliness in dyad • Enhanced social interactions • Greater independence for person with dementia • Greater companion respite | • Enhanced self-efficacy • Improved communication • Greater functional ability (BADLS) • Reduced apathy (NPI-12) • Relationship satisfaction is higher (RSS) in both person with dementia and companion • Companions health and well-being (SF-12; GHQ-12; FCS; HADS) | • Quality of life in PwD (DEMQoL) |
Training in correct use of hearing aid /glasses with dyad | |||||
Communication Training with dyad | |||||
Home-based functional assessment and tailored interventions to address support care needs enabled | |||||
Opportunity (O) (external factors which impact on the individual’s ability to ‘live well’ with dementia) | Provision of supplementary sensory devices | • Hear and see better (HHIE-25;VA-LVVFQ-20) • Appropriate levels of support from companion | |||
Referral to health and social care services | • Uptake of health and social care services • Uptake of social/hobby/ interest opportunities • Enhanced cognitive stimulation • Achievement of set goals | ||||
Referral to social/hobby/interest activities | |||||
Motivation (M) (in dementia, apathy and loss of motivation is prevalent and may make behavioural change difficult) | Individualised goal setting | ||||
Referral to social/hobby/ interest activities | • Enhanced uptake and adherence of sensory aids and suggested social opportunities • Uptake of meaningful and enjoyable social/hobby/interest activities |
Identification of key uncertainties and developing a framework for the process evaluation
Sensory support intervention component | Key uncertainty to address |
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Correct visual/auditory impairment | Is vision/hearing impairment actually corrected? |
Training in correct use of hearing aid/glasses | How well are the devices used by the PwD? |
Communication training | Is the companion utilising the techniques? |
Home-based functional assessment | What are the types and extent of functional impairment identified by the sensory support therapist? |
Referral to health and social care services | What types of services are available at each site? How many referrals were made and actioned? |
Provision of supplementary sensory devices in the home environment | How many of these were supplied and how often and effectively were they used? |
Referral to social/hobby/interest activities | How many referrals were made and actioned? |
Individualised goal setting | What is the number and types of goals set with the participant? How many goals were achieved? What is the level of apathy present (ascertained only after final assessment data collected? |
Measurement tool | Data captured by whom? About whom/what? | Timing of data capture | Process evaluation (Capability ´C´, Opportunity ´O´, Motivation ´M´) and measurement instruments (details) | |
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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 |