Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02641275
Status:
WITHDRAWN
Last Update Posted:
2019-08-19
First Post:
2015-11-09
Brief Title:
Self-management Training for Parents With Chronic Muscular Dystrophia
Sponsor:
University Childrens Hospital Zurich
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
Self-management Training for Parents With Chronic Muscular Dystrophia
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We could not enrole or recruite enough participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZRM-CMD-P
Brief Summary:
The relentless progressive process of muscular dystrophy requires extraordinary medical physical and emotional care with severe consequences for caring parents increased stress and diminished social psychological and physical well-being Despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies The presenting study aims to fill this gap by evaluating the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual TAU In addition investigators measure established biomarkers of psychosocial stress such as pro-inflammatory cytokines which will be used to monitor physiological changes with assumed significance for parental health
Detailed Description:
Background
The relentless progressive process of muscular dystrophy requires extraordinary medical physical and emotional care As a consequences caring for a patient with a severe chronic illness has been associated with increased stress and diminished social psychological and physical well-being in parents According to Thompson et al 57 of parents with Duchenne muscular dystrophy children have self-reported poor psychological adjustment and even in comparison with parents of children with other burdens like cerebral palsy or renal diseases muscular dystrophy was associated with a wider spectrum of problems and parental stress Moreover parents are shown to have significant stress by feelings of guilt and associated difficulty discussing death issues with their children
However despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies In practice they are mostly limited to meetings of self-help groups and casual exchange between concerned parents which is rather a problem-centered than proactive solution-focused approach As a consequence investigators see a great need for studies regarding more specific interventions supporting parents self-management skills coping strategies and competencies
Objectives
The present study evaluates the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual TAU In addition investigators measure established biomarkers of psychosocial stress such as pro-inflammatory cytokines which will be used to monitor physiological changes with assumed significance for parental health
Methods
Participants will fill out online-questionnaires before during and after self-management training Training interventions will take place in Zurich as group sessions 10-20 participants per group Investigators aim for a total of 60-80 participants Parent-couples or single participants will be randomized in an intervention group participants receiving self-management training and a non-intervention group participants continue with already established support After one year parents from the non-intervention group will change into the intervention group with self- management training as well Questionnaires focus on assessing parental strain and self- efficacy and will take 30-45minutes for each of four surveys Validated biological markers such as cumulative cortisol levels in hair and pro-inflammatory cytokines in the blood will be collected before and after self-management trainings
The relentless progressive process of muscular dystrophy requires extraordinary medical physical and emotional care As a consequences caring for a patient with a severe chronic illness has been associated with increased stress and diminished social psychological and physical well-being in parents According to Thompson et al 57 of parents with Duchenne muscular dystrophy children have self-reported poor psychological adjustment and even in comparison with parents of children with other burdens like cerebral palsy or renal diseases muscular dystrophy was associated with a wider spectrum of problems and parental stress Moreover parents are shown to have significant stress by feelings of guilt and associated difficulty discussing death issues with their children
However despite the obvious need of support for parents only few and weak data exist regarding efficiency and efficacy of specific interventions supporting parental resilience and coping strategies In practice they are mostly limited to meetings of self-help groups and casual exchange between concerned parents which is rather a problem-centered than proactive solution-focused approach As a consequence investigators see a great need for studies regarding more specific interventions supporting parents self-management skills coping strategies and competencies
Objectives
The present study evaluates the efficacy of a structured self-management training for parents of children with severe progressive muscular dystrophy compared to parents receiving treatment as usual TAU In addition investigators measure established biomarkers of psychosocial stress such as pro-inflammatory cytokines which will be used to monitor physiological changes with assumed significance for parental health
Methods
Participants will fill out online-questionnaires before during and after self-management training Training interventions will take place in Zurich as group sessions 10-20 participants per group Investigators aim for a total of 60-80 participants Parent-couples or single participants will be randomized in an intervention group participants receiving self-management training and a non-intervention group participants continue with already established support After one year parents from the non-intervention group will change into the intervention group with self- management training as well Questionnaires focus on assessing parental strain and self- efficacy and will take 30-45minutes for each of four surveys Validated biological markers such as cumulative cortisol levels in hair and pro-inflammatory cytokines in the blood will be collected before and after self-management trainings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None