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Informed decision-making with and for people with dementia – evaluation of an education program for legal representatives

Informed decision-making with and for people with dementia – efficacy of the PRODECIDE education program for legal representatives in a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17960111
Enrollment
216
Registered
2017-06-01
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Proxy decision-making for people with dementia Mental and Behavioural Disorders Unspecified dementia

Interventions

The PRODECIDE-RCT is a randomized controlled superiority trial with two parallel groups, a 1:1 randomization and a six-month follow-up. Legal representatives will be allocated to the intervention grou

Sponsors

Deutsche Forschungsgemeinschaft
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Legal representatives in Germany, both professional and volunteer 2. Represent at least one person with dementia (assessed by the legal representative and/or medical diagnosis)

Exclusion criteria

Exclusion criteria: Participation in the PRODECIDE education program (either the whole program or a single module)

Design outcomes

Primary

MeasureTime frame
Knowledge (understanding of decision-making processes in healthcare affairs and realistic expectations regarding probabilities of benefits and harms of percutaneous endoscopic gastrostomy, physical restraints and antipsychotics to people with dementia), assessed using a novel questionnaire at T1 (up to 2 weeks after intervention)

Secondary

MeasureTime frame
1. Sufficient knowledge, measured with the same knowledge test as the primary outcome using a cut-off of 70% correct answers, at T1 (up to 2 weeks after intervention) 2. Sustainable knowledge, assessed with the same knowledge test at T3 (6-month follow-up) 3. The use of percutaneous endoscopic gastrostomies, physical restraints and antipsychotics, using data extracted from routine documentation and standardized documentation sheets at baseline and T3 (6-month follow-up) 4. Result of the first decision after intervention regarding percutaneous endoscopic gastrostomy, physical restraints and antipsychotics, assessed using documentation sheets and telephone interviews at T2 (3-month follow-up) and T3 (6-month follow-up)

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026