Self-management Training for Parents With Chronic Muscular Dystrophia (ZRM-CMD-P)
Primary Purpose
Muscular Dystrophies
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured self-management-training
Sponsored by
About this trial
This is an interventional supportive care trial for Muscular Dystrophies focused on measuring Parental stress, Muscular Dystrophies, Coping, Parental support
Eligibility Criteria
Inclusion Criteria:
- Parents with at least one living child affected by chronic muscular dystrophy
Exclusion Criteria:
- Dying of a child during intervention and analysis.
- Severe/significant psychological disorder (in case of existing psychological support, participation should be agreed/supported by therapist, too)
- Recent or concomitant self-management training
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control group
Arm Description
Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.
no intervention other than existing support (see exclusion criteria). However, intervention will be offered and studied secondary as well (after 1 1/2 year of no intervention).
Outcomes
Primary Outcome Measures
Action Orientation Questionnaire (HAKEMP)
Kuhl and co-workers introduced a special questionnaire (HAKEMP) to assess the tendency of people in concrete situations to revert to an action-oriented or state-oriented condition in 24 items.
Self-efficacy: Thought control of action (SWE)
Quantify improved parental resilience and coping strategies facing chronic stress. Questionnaire developed by Jerusalem and Schwarzer, 1981, revised 1999 to test general self-efficacy in 10 items.
Change in Experiencing and Behaviour post-intervention (VEV)
VEV is a questionnaire developed by Ziele and Kopf-Mehnert, 1978 to test post-intervention change in experiencing and behavior along with a retrospective life-event checklist and a self-rating questionnaire in 42 items. Other than previous questionnaires VEV will be applied only after intervention.
Secondary Outcome Measures
Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress
Significant lower levels of biomarkers of psychosocial stress, i.e. pro-inflammatory cytokines, which can be used to monitor physiological changes with assumed significance for parental health: C-reactive Protein (hsCRP), Tumor-Necrose-Factor alpha (TNFα), Interleukin (IL)-1ß, IL-6, und Interferon Gamma (IFNγ). Items will be aggregated as a numerical factor which shows the difference of a measured value from a reference value . Abnormal laboratory values therefore will be used as a sum.
Full Information
NCT ID
NCT02641275
First Posted
November 9, 2015
Last Updated
August 14, 2019
Sponsor
University Children's Hospital, Zurich
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02641275
Brief Title
Self-management Training for Parents With Chronic Muscular Dystrophia
Acronym
ZRM-CMD-P
Official Title
Self-management Training for Parents With Chronic Muscular Dystrophia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
We could not enrole or recruite enough participants.
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
Collaborators
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies
Keywords
Parental stress, Muscular Dystrophies, Coping, Parental support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention other than existing support (see exclusion criteria). However, intervention will be offered and studied secondary as well (after 1 1/2 year of no intervention).
Intervention Type
Other
Intervention Name(s)
Structured self-management-training
Intervention Description
Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions
Primary Outcome Measure Information:
Title
Action Orientation Questionnaire (HAKEMP)
Description
Kuhl and co-workers introduced a special questionnaire (HAKEMP) to assess the tendency of people in concrete situations to revert to an action-oriented or state-oriented condition in 24 items.
Time Frame
1 1/2 year with control group
Title
Self-efficacy: Thought control of action (SWE)
Description
Quantify improved parental resilience and coping strategies facing chronic stress. Questionnaire developed by Jerusalem and Schwarzer, 1981, revised 1999 to test general self-efficacy in 10 items.
Time Frame
1 1/2 year with control group
Title
Change in Experiencing and Behaviour post-intervention (VEV)
Description
VEV is a questionnaire developed by Ziele and Kopf-Mehnert, 1978 to test post-intervention change in experiencing and behavior along with a retrospective life-event checklist and a self-rating questionnaire in 42 items. Other than previous questionnaires VEV will be applied only after intervention.
Time Frame
1 1/2 year with control group
Secondary Outcome Measure Information:
Title
Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress
Description
Significant lower levels of biomarkers of psychosocial stress, i.e. pro-inflammatory cytokines, which can be used to monitor physiological changes with assumed significance for parental health: C-reactive Protein (hsCRP), Tumor-Necrose-Factor alpha (TNFα), Interleukin (IL)-1ß, IL-6, und Interferon Gamma (IFNγ). Items will be aggregated as a numerical factor which shows the difference of a measured value from a reference value . Abnormal laboratory values therefore will be used as a sum.
Time Frame
1 1/2 year with control group
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parents with at least one living child affected by chronic muscular dystrophy
Exclusion Criteria:
Dying of a child during intervention and analysis.
Severe/significant psychological disorder (in case of existing psychological support, participation should be agreed/supported by therapist, too)
Recent or concomitant self-management training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürg C Streuli, MD PhD
Organizational Affiliation
University Children's Hospital, Zurich
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Self-management Training for Parents With Chronic Muscular Dystrophia
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