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Table 2 PICO for trials and INCLUDE framework used for theoretical redesign

From: Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials

 

Stroke trial

Meeting date: 16/06/2022

Depression trial

Meeting date: 02/09/2022

Diabetes trial

Meeting date: 03/10/2022

Population;

Recruitment setting

Care home residents with confirmed or suspected stroke; Care homes.

Adults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9); Primary care/General Practices (GPs)

Patients with Diabetic Peripheral Neuropathic Pain (DPNP); Secondary care/hospitals.

Intervention

Occupation therapy (OT) package was delivered to residents and care home staff.

Two intervention groups: two types of online Cognitive Behavioural Therapy.

Six sequences consisting of 3 drug pathways.

Comparator

Usual care.

Usual care by their GP.

Placebo.

Outcome

Barthel Index score (assesses dependency).

Depression severity and symptomatology as measured by a validated self-report measure (PHQ-9).

7-day average 24-h pain (evaluated at patient level) on an 11 point Numeric rating Scale (0 = no pain and 10 = worst pain imaginable).

INCLUDE framework used

Impaired capacity to consent framework [8].

Socio-economic disadvantage framework [7].

Ethnicity framework [6].