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Randomised controlled trial and cost-effectiveness evaluation of an interactive video system to promote shared decision making in general practice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37846533
Enrollment
112
Registered
2004-01-23
Start date
1996-01-01
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

Urological and genital diseases: Other urological and genital disease Urological and Genital Diseases Benign prostatic hypertrophy

Interventions

Patients with clinical diagnosis of benign prostatic hypertrophy were referred into the study by their General Practitioner (GP). The intervention group received an information package consisting of a
the control group received normal care only. Data were collected at baseline, three months and nine months.

Sponsors

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men attending participating general practices with a clinical diagnosis of benign prostatic hypertrophy and sufficient command of English to consult without an interpreter 2. Any clinical suggestion of carcinoma of the prostate 3. Chronic retention of urine 4. Recent urinary tract infection 5. Recent acute urinary retention 6. History of prostate surgery 7. Severe visual or hearing impairment, such that the patient could not use the decision aid 8. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision

Exclusion criteria

Exclusion criteria: 1. Any clinical suggestion of carcinoma of the prostate 2. Chronic retention of urine 3. Recent urinary tract infection 4. Recent acute urinary retention 5. History of prostate surgery 6. Severe visual or hearing impairment, such that the patient could not use the decision aid 7. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision

Design outcomes

Primary

MeasureTime frame
Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

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