The main goal of the study is to measure the effectiveness of the Patient and Partner Education program 4 all (PPEP4ALL) in patients with hypoxic brain injury and/or their spouse/caregiver.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the quality of life (SF-36) of the patients and the
experienced strain of the caregiver (Caregiver Strain Index).
Secondary outcome
Clinical outcomes are:
• Experienced cognitive complaints(Cognitive Failure Questionnaire),
• Experienced cognitive changes by the spouse/care giver (Informant
Questionnaire on Cognitive Decline in the Elderly),
• Effects towards autonomy and partipation (Impact on Participation and
Autonomy)
• Severity of fear and derpession (Hospital Anxiety and Depression Scale)
• Amount of care of patients and caregiver/spuse (focus group)
• Cognitive functioning (Montreal Cognitive Assessment)
outcomes process:
• Satisfaction of patient, partner and trainer towards the followed/given
intervention (Visual Analoge Scale)
• Any necessary modifications made in the existing PPEP4All workbooks and
meetings.
Background summary
The main goal of a rehabilitation centre is to help patients and their spouse
to return back as good as possible to society after an event.
To optimize the care for patients after a cardiac arrest patients who start
rehabilitation in the RRC are being screened for possible cognitive deficits or
complaints due to hypoxic brain injury.
Patients with cognitive complaints are offered a cognitive rehabiliation
program after the regular cardiac rehab program. At the moment the RRC wants to
provide a selfmanagement program for patients and spouse who experience
difficulties due to persisting cognitive damage. By introducing a patient and
partner education program the RRC can provide a structured therapy for patients
with cognitive problems. The program can also provide in adjusted counseling
for the spouse which at the moment is experienced as insufficient.
Study objective
The main goal of the study is to measure the effectiveness of the Patient and
Partner Education program 4 all (PPEP4ALL) in patients with hypoxic brain
injury and/or their spouse/caregiver.
Study design
This randomised controled prospective study includes patients with stbale
cognitive complaints (>= * year after OHCA) and/or their partner. Patients
are recruited in the region Leiden by the Rijnlands Rehabilitation Centre,
local hospitals (LUMC, Diaconessen en Rijnland Ziekenhuis) and local news
papers. If necessary patients will also be recuited at the Sophia
Rehabilitation Den Haag or the Spaarne Hospital at Nieuw Vennep who have a
collaborating link with the RRC.
Patients and/or partners will take part in the PPEP4All during 8 weeks which
will be held at the RRC, Leiden.
To achieve the aim of this project the following five fases will be carried out:
Fase 1: a deepening literature study and write roadmap/script.
Fase 2: recruit subjects
Fase 3: introduce intervention to subjects.
Fase 4: Analyses and report
Fase 5: Write standard module and implement
Planning schedual
The controled part of the study will take two years. The intervention will be
given in a group during eight weeks. A group exists of 4 to 7 patients and
their spouse/care giver (in total 8 to 10 groups). The period of the controled
part of the study will cover 95 weeks and 125 weeks including the final
measurements of the not controlled part of the study.
Intended date to start: 1st of April 2014.
Study burden and risks
to fill in the questionnaires takes extra time for the patient and partner/care
giver which can be experienced as cumbersome. Also the intervention can be
experienced as fysically or metally cumbersome.
Wassenaarseweg 501
Leiden 2333AL
NL
Wassenaarseweg 501
Leiden 2333AL
NL
Listed location countries
Age
Inclusion criteria
minimum 1/2 year after cardiac arrest; survival after cardiac arrest; cognitive complaints objectified with MoCA, CFQ and IQCODE; age >=18 years; <5 years after cardiac arrest; patients and partners can join individually or together.
Exclusion criteria
patients: bad physical state; braindamage not due cardiac arrest; insufficient use of dutch language; restrictive behavioural problems;affecting psychiatric comorbidity;partners: restrictive behavioural problems; insufficient use of Dutch langauge; bad physical state
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47704.058.14 |