Decision Analysis in Routine Treatment II: a randomised controlled trial (efficacy study) of a decision aid to support shared decision making for patients with atrial fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24808514

Enrollment

109

Registered

2002-11-06

Start date

2001-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation (AF)

Interventions

Patients randomised to one of three interventions: 1. Explicit DARTS tool - full shared decision making tool 2. Implicit DARTS tool - shortened version of shared decision making tool 3. Evidence based

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged over 60 with non-valvular atrial fibrillation on aspirin, warfarin or no anti-thrombotic treatment

Exclusion criteria

Exclusion criteria: 1. Acute onset requiring cardiological referral for consideration of cardioversion 2. Had a previous stroke or Transient Ischaemic Attack (TIA) 3. Have absolute contraindications to warfarin 4. Suffer from dementia or cognitive impairment sufficient to hinder shared decision making

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the decision conflict scale. Prior to clinic attendance patients will complete scales on decision conflict, their choice predisposition, knowledge, decision making preference, general anxiety and risk factors/demographic information. Immediately following the clinic, patients will complete scales on decision conflict, knowledge, decision making role experienced, and anxiety. At three months, patients will be sent follow-up postal questionnaires including the decision conflict scale, decision making preference scale and the knowledge scale.	—

Measure

Time frame

The primary outcome measure is the decision conflict scale. Prior to clinic attendance patients will complete scales on decision conflict, their choice predisposition, knowledge, decision making preference, general anxiety and risk factors/demographic information. Immediately following the clinic, patients will complete scales on decision conflict, knowledge, decision making role experienced, and anxiety. At three months, patients will be sent follow-up postal questionnaires including the decision conflict scale, decision making preference scale and the knowledge scale.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026