WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

Table 1 WHEDA measurement scheme

		Week
Variable	Instrument	-1	0	6	11	16	21	26	32	38	45	52
Primary outcome
Patients' functioning in everyday life	IDDD, PRPP-Video rating		X	X		X		X
Secondary outcome patient
Quality of life	DQoL, SF-12		X	X		X		X
Mood	CSDD		X	X		X		X				X
Resource utilisation incl. informal care	Adapted RUD (+ diary as reminder)		X	X	X	X	X	X	X	X	X	X
Satisfaction with treatment	5-point-Likert-scale and comments			X
Long-term institutionalisation	Adapted RUD (+ diary as reminder)		X	X	X	X	X	X	X	X	X	X
Secondary outcome caregiver
Competence in interaction with patient	SCQ		X	X		X		X				X
Quality of life	DQoL, SF-12		X	X		X		X				X
Mood	CES-D		X	X		X		X				X
Resource utilisation	Adapted RUD (+ diary as reminder)		X	X	X	X	X	X	X	X	X	X
Satisfaction with treatment	5-point-Likert-scale and comments			X
Control measures
Demographic data	Socio-demographic questionnaire		X
Depression	GDS	X
Cognition	MMSE	X			X		X
Medication	Adapted RUD (+ diary as reminder)		X	X	X	X	X	X	X	X	X	X
Periods of illness	Adapted RUD (+ diary as reminder)		X	X	X	X	X	X	X	X	X	X
Process measures
Adherence to manual (therapist)	Evaluation form for every treatment			X
Adherence of patient and caregiver	Structured therapist questionnaire				When treatment period is finished
Adherence to protocol (therapist)	Structured therapist questionnaire				When treatment period is finished
Adherence to protocol (study centres)	Deviations of protocol schedule	Continuous registration

ISSN: 1471-2318