Table 2 Sub-studies included in the process of developing a complex intervention

Expert Reference Group

To scope expert opinions on gaps in understanding of the support care needs and potential solutions for people with cognitive and sensory problems

Expert professionals from several disciplines (audiology, vision science, ophthalmology, optometry, health psychology, social work, occupational psychology, occupational therapy and social gerontology)

Three components:

1. Discussion of assessment and management of prototypical cases

2. Analysis of implementation of existing complex dementia trials

3. A modified Delphi to establish a list of support care needs

A two-day meeting in Athens, Greece

Prototypical case discussions will be transcribed and subject to content analysis

Focus group A

To scope the needs of people with dementia and sensory impairment

Three focus groups (n = 8 per group) will be conducted with people with dementia and sensory impairment, their study partners and professionals in three sites

Focus groups will be used to discuss support care needs of this population

Three focus groups will take place in each of three sites (total of nine groups): Manchester, Nicosia and Bordeaux

Conversations will be transcribed using MAXQDA software and subjected to content analysis. Cross-site differences will be explored within the analysis of these discussions

Needs analysis survey

To scope the support care needs of people with dementia and sensory impairment

People with dementia and sensory impairment and their study partner. Three sites will recruit between 30 and 40 dyads each

A series of questionnaires will be used to scope the needs, quality of life, degree of impairment, caregiver burden, mental and physical health of participants

Manchester will be the site for 40 participant dyads; Nicosia and Bordeaux will each recruit 30 dyads (total of 100 dyads).

Regression analyses will be used to explore the relationships between variables

Focus group B

To receive feedback on a draft intervention

Three focus groups (n = 8 in each group) will be run using professionals, people with dementia, and their study partners

Information from the preceding stages will be integrated to inform a draft intervention, which which will be presented to participants for comment and feedback

These will be the same three sites that participated in focus group A; however, the participants may differ between the two focus groups

As with focus group A, discussions will be transcribed and analysed using content analysis

Field Trial of draft intervention

To trial a ‘sensory support’ intervention for people with dementia and sensory impairment

Eight participant dyads (people with dementia and sensory impairment and their study partners) in each of three sites

A 12-week ‘sensory support’ intervention involving correction of hearing/vision impairments, communication training, ‘sensory proofing’ the home environment, and signposting to relevant services. Baseline and follow-up data will be collected along with process measures and reflective diaries

Three sites will recruit a total of 24 participant dyads: Manchester, Nicosia, and Bordeaux

Data from the diaries and verbatim data from the interviews will be analysed using a summative content analysis.

Quantitative parametric data will be analysed using two-tailed t tests, with 95% CIs. Effect sizes using the Hedges’ g formula (similar to Cohen’s d), appropriate for small sample sizes will be calculated. Due to the small sample, only a large p value, 0.2, will be an indication of effect. The score distributions will be examined for degree of variability and ceiling and floor effects.

Participants’ subjective report of the overall helpfulness of the intervention will give an initial impression of efficacy. An initial impression of treatment efficacy will be obtained by examining before and after-intervention measures of a variety of rating scales of dementia-related outcomes