Development study 3: field testing of the intervention for final refinement prior to the main trial

Vasiliki Orgeta; Phuong Leung; Lauren Yates; Sujin Kang; Zoe Hoare; Catherine Henderson; Chris Whitaker; Alistair Burns; Martin Knapp; Iracema Leroi; Esme D Moniz-Cook; Stephen Pearson; Stephen Simpson; Aimee Spector; Steven Roberts; Ian T Russell; Hugo de Waal; Robert T Woods; Martin Orrell

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Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.64.)

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Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.

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Appendix 3Development study 3: field testing of the intervention for final refinement prior to the main trial

TABLE 45

Demographic characteristics of people with dementia and carers taking part in field testing: Development study 3

Demographic characteristics, N = 25
Family caregiving dyads, n = 19
People with dementia
Age, mean (SD)	80.60 (5.15)
Sex, %
Male	47.4
Female	52.6
Ethnicity, %
White	78.9
Black	5.3
Unknown	15.8
Living status, %
Living with spouse	42.1
Living with adult child	15.8
Living alone	26.3
Unknown	15.8
Carers
Age, mean (SD)	65.00 (10.52)
Sex, %
Male	21.1
Female	78.9
Ethnicity, %
White	84.2
Mixed	5.3
Unknown	10.5
Relationship, %
Spouse	57.9
Adult child	42.1
Years caring, mean (SD)	4.32 (1.87)
Paid caregiving dyads, n = 6
People with dementia
Age, mean (SD)	83.25 (8.22)
Sex, %
Male	50.0
Female	50.0
Ethnicity, %
White	83.3
Unknown	16.7
Living status, %
Living alone	83.3
Living with paid carer	16.7
Carers
Age, mean (SD)	42.6 (16.13)
Sex, %
Male	16.7
Female	83.3
Ethnicity,%
White	33.3
Black	33.3
Mixed	33.3
Years caring, mean (SD)	1.75 (1.50)

TABLE 46

Number of sessions completed by participants during field testing: Development study 3

Sessions completed (range 4–24) (N = 9)
0–6, n (%)	1 (11)
7–11, n (%)	5 (56)
12–16, n (%)	2 (22)
17–24, n (%)	1 (11)
Mean number of sessions, n (SD)	11.56 (5.59)

TABLE 47

Evaluation ratings of iCST sessions during the field-testing phase: Development study 3

Evaluation ratings of iCST sessions, (n = 9)
iCST theme		Frequency
iCST theme		Interest	Communication	Enjoyment	Difficulty level
My life sessions (6 ratings)	Not at all (1)	0	0	0	0
	A little (2)	0	0	0	4
	Moderately (3)	6	1	4	2
	Quite a lot (4)	0	5	2	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.00 (0.00)	3.83 (0.41)	3.33 (0.52)	2.33 (0.52)
Current affairs (4 ratings)	Not at all (1)	1	0	1	1
	A little (2)	0	2	1	1
	Moderately (3)	1	0	2	2
	Quite a lot (4)	2	2	0	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.00 (1.41)	3.00 (1.15)	2.25 (0.95)	2.25 (0.96)
Food (6 ratings)	Not at all (1)	1	0	2	1
	A little (2)	3	2	2	0
	Moderately (3)	0	0	0	2
	Quite a lot (4)	2	4	2	1
	Extremely (5)	0	0	0	2
Mean ratings (SD)		2.50 (1.22)	3.33 (1.03)	2.33 (1.37)	3.50 (1.51)
Being creative (5 ratings)	Not at all (1)	2	2	2	4
	A little (2)	0	1	0	1
	Moderately (3)	1	0	1	0
	Quite a lot (4)	2	2	2	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		2.50 (1.22)	3.33 (1.03)	2.33 (1.37)	3.50 (1.51)
Number games (4 ratings)	Not at all (1)	0	0	0	2
	A little (2)	1	0	2	1
	Moderately (3)	1	2	2	1
	Quite a lot (4)	2	2	0	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.25 (0.96)	3.50 (0.58)	2.50 (0.58)	1.75 (0.96)
Quiz games (2 ratings)	Not at all (1)	0	0	0	2
	A little (2)	0	0	0	0
	Moderately (3)	0	0	0	0
	Quite a lot (4)	2	1	1	0
	Extremely (5)	0	1	1	0
Mean ratings (SD)		3.25 (0.96)	3.50 (0.58)	2.50 (0.58)	1.75 (0.96)
Sounds (3 ratings)	Not at all (1)	0	0	2	0
	A little (2)	0	0	0	1
	Moderately (3)	0	0	1	0
	Quite a lot (4)	3	3	0	2
	Extremely (5)	0	0	0	0
Mean ratings (SD)		4.00 (0.00)	4.00 (0.00)	1.67 (1.15)	3.33 (1.15)
Physical games (6 ratings)	Not at all (1)	0	0	0	4
	A little (2)	0	0	0	0
	Moderately (3)	2	2	2	2
	Quite a lot (4)	2	0	2	0
	Extremely (5)	2	4	2	0
Mean ratings (SD)		4.00 (0.89)	4.33 (1.03)	4.00 (0.89)	1.67 (1.03)
Categorising objects (6 ratings)	Not at all (1)	0	0	0	2
	A little (2)	0	0	0	4
	Moderately (3)	4	4	2	0
	Quite a lot (4)	2	2	4	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.33 (0.52)	3.33 (0.52)	3.67 (0.52)	1.67 (0.52)
Household treasures (6 ratings)	Not at all (1)	0	0	0	2
	A little (2)	0	0	0	4
	Moderately (3)	4	2	6	0
	Quite a lot (4)	2	4	0	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.33 (0.52)	3.67 (0.52)	3.00 (0.00)	1.67 (0.52)
Useful tips (5 ratings)	Not at all (1)	0	0	1	2
	A little (2)	0	0	0	2
	Moderately (3)	3	1	2	1
	Quite a lot (4)	2	4	2	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.40 (0.55)	3.80 (0.44)	3.00 (1.22)	1.80 (0.84)
Thinking cards (2 ratings)	Not at all (1)	0	0	0	0
	A little (2)	0	0	0	2
	Moderately (3)	0	0	0	0
	Quite a lot (4)	2	2	2	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		4.00 (0.00)	4.00 (0.00)	4.00 (0.00)	4.00 (0.00)
Art discussion (4 ratings)	Not at all (1)	0	0	0	4
	A little (2)	0	0	0	0
	Moderately (3)	2	0	0	0
	Quite a lot (4)	0	2	2	0
	Extremely (5)	2	2	2	0
Mean ratings (SD)		4.00 (1.15)	4.50 (0.58)	4.50 (0.58)	1.00 (0.00)
Faces/scenes (4 ratings)	Not at all (1)	0	0	0	2
	A little (2)	0	0	0	0
	Moderately (3)	0	0	2	2
	Quite a lot (4)	4	4	2	0
	Extremely (5)	0	0	0	0
Mean ratings (SD)		4.00 (0.00)	4.00 (0.00)	3.50 (0.58)	2.00 (1.15)
Word games (14 ratings)	Not at all (1)	0	0	0	8
	A little (2)	0	0	0	2
	Moderately (3)	0	2	2	4
	Quite a lot (4)	12	8	4	0
	Extremely (5)	2	4	8	0
Mean ratings (SD)		4.14 (0.36)	4.14 (0.66)	4.43 (0.75)	1.71 (0.91)
Slogans and visual clips (4 ratings)	Not at all (1)	0	0	2	2
	A little (2)	0	0	0	0
	Moderately (3)	2	2	0	0
	Quite a lot (4)	2	2	2	2
	Extremely (5)	0	0	0	0
Mean ratings (SD)		3.50 (0.58)	3.50 (0.58)	2.50 (1.73)	2.50 (1.73)
Orientation (7 ratings)	Not at all (1)	0	0	2	2
	A little (2)	2	2	2	2
	Moderately (3)	5	4	1	1
	Quite a lot (4)	0	1	2	0
	Extremely (5)	0	0	0	2
Mean ratings (SD)		2.71 (0.48)	2.86 (0.69)	2.43 (1.27)	2.71 (1.70)
Using money (6 ratings)	Not at all (1)	0	0	0	4
	A little (2)	2	0	0	0
	Moderately (3)	2	4	4	2
	Quite a lot (4)	0	0	0	0
	Extremely (5)	2	2	2	0
Mean ratings (SD)		3.33 (1.37)	3.67 (1.03)	3.67 (1.03)	1.67 (1.03)
Childhood (4 ratings)	Not at all (1)	0	0	0	2
	A little (2)	0	0	0	0
	Moderately (3)	0	0	0	2
	Quite a lot (4)	4	2	2	0
	Extremely (5)	0	2	2	0
Mean ratings (SD)		4.00 (0.00)	4.50 (0.58)	4.50 (0.58)	2.00 (1.54)

TABLE 48

Information collected during set-up visits to inform main trial: Development study 3 (n = 22; family carers only)

Carer ratings			Researcher ratings
	%	Mean (SD)		%	Mean (SD)
iCST knowledge		3.04 (1.00)	Success of set-up visit		3.77 (0.75)
Poor (1)	0		Poor (1)	0
Fair (2)	31.8		Fair (2)	0
Good (3)	45.5		Good (3)	41.2
Very good (4)	9.1		Very good (4)	41.2
Excellent (5)	13.6		Excellent (5)	17.6
Confidence in iCST		3.95 (0.78)	Successful engagement		3.70 (0.47)
Very little (1)	0
Some (2)	0		Not at all (1)	0
Fair (3)	31.8		A little (2)	0
Good (4)	40.9		Quite a bit (3)	29.4
Very confident (5)	27.3		A lot (4)	70.6
Support required		2.10 (0.55)	Support required		1.52 (0.51)
Not at all (1)	5.0		Not at all (1)		47.1
A little (2)	85.0		A little (2)		52.9
Quite a lot (3)	5.0		Quite a bit (3)		0
A lot (4)	5.0		A lot (4)		0
Training arrangement
Own home	54.5
In groups	22.7
Either	22.7

TABLE 49

Qualitative findings of the field-testing phase using standardised telephone interviews: Development study 3 (n = 22)

Themes	Family carers	Paid carers
Barriers in iCST delivery	Time/availability Health of person with dementia/carer Job/family commitments Difficulties motivating/engaging person with dementia Life events	Carer on annual leave Difficulties motivating/engaging person with dementia Life events Health of the person with dementia Visits suspended or person with dementia on holiday
Barriers specific to iCST activities/programme	Using opinion rather than facts Person with dementia finds activities difficult Locating resources to use	Person with dementia demotivated if activity is too easy
iCST programme/structure	Doing sessions in ‘chunks’ Make sessions feel ‘informal’ Separate orientation with current affairs Skip orientation discussion Repeating sessions out of order helpful	Make sessions feel ‘informal’ Completing sessions out of order helpful
Frequency/duration of iCST sessions	Difficult to complete three sessions weekly Sessions last longer than 30 minutes	Feasible to complete three sessions weekly
iCST manual	Easy to use Promotes discussion/ideas Provides variation in difficulty of activities	Easy to use Important to adjust ratings of difficulty Remove reference to ‘person with dementia’
iCST resources	Feasible to use own resources when prompted	Feasible to use own resources when prompted
Response to the iCST activities from the person with dementia	Enjoying activities Asking questions can make person nervous Mood is lifted, sense of achievement Improvements in conversation	Enjoying activities Mood is lifted Person interested/engaged in activities
Caregiving relationship	Gives carer a sense of purpose Brings dyad ‘closer together’ Activities help dyad to communicate Opportunities to laugh together Carer is giving person more of their time
Support in delivering iCST	None needed Friends and family help with sessions Family is often too busy to help	None needed Family members help with sessions

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Orgeta et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK311127

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Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.64.) Appendix 3, Development study 3: field testing of the intervention for final refinement prior to the main trial.
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