Muscular DystrophiesZRM-CMD-PNCT02641275
Self-management Training for Parents With Chronic Muscular Dystrophia
A study testing Structured self-management-training in people with Muscular Dystrophies, run by University Children's Hospital, Zurich.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- Structured self-management-training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents with at least one living child affected by chronic muscular dystrophy
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Muscular Dystrophies
- Being tested
- Structured self-management-training
- Keywords
- Parental stress, Muscular Dystrophies, Coping, Parental support
- Medical subject headings
- Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured self-management-trainingOther
Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions. Receives: Other: Structured self-management-training |
| Control group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 1/2 year with control group
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.
Measured: 1 1/2 year with control group
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.
Measured: 1 1/2 year with control group
Secondary outcomes (1)
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.
Measured: 1 1/2 year with control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: We could not enrole or recruite enough participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Jürg C Streuli, MD PhD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641275
- Sponsor's protocol ID
- ZRM-CMD Parents
- Acronym
- ZRM-CMD-P
- Status last verified
- Aug 2019
- First submitted
- 9 Nov 2015
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management Training for Parents With Chronic Muscular Dystrophia
- ClinicalTrials.gov ID
- NCT02641275
- Acronym / sponsor ID
- ZRM-CMD-P / ZRM-CMD Parents
- Conditions
- Muscular Dystrophies
- Keywords
- Parental stress, Muscular Dystrophies, Coping, Parental support
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not enrole or recruite enough participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured self-management-trainingStructured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions. |
| Control group | No intervention | –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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents with at least one living child affected by chronic muscular dystrophy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured self-management-trainingStructured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions | Other | Intervention |
Primary outcome
Action Orientation Questionnaire (HAKEMP)
Time frame: 1 1/2 year with control group
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)
Time frame: 1 1/2 year with control group
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)
Time frame: 1 1/2 year with control group
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.
1 secondary outcome
Number of Participants With Sum of Abnormal Laboratory Values Concerning Biomarkers of psychosocial stress
Time frame: 1 1/2 year with control group
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Related trials for Muscular Dystrophies
RecruitingEarly Phase 1
Safety and Dystrophin Expression of SPOT-03 in Duchenne Muscular Dystrophy (DMD) Patients
Duchenne Muscular Dystrophy (DMD)
RecruitingPhase 2
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
RecruitingObservational study
Preclinical Assessment of an Engineered HMGB1 Protein as a Novel Companion Therapy for Muscular Dystrophies
LAMA2-MD (Merosin Deficient Congenital Muscular Dystrophy, MDC1A)
Not yet recruitingPhase 2
A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD)
Enrolling by invitationObservational study
Personalized Disease Modeling for Rare Genetic Myopathies
Congenital Myopathies, Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürg C Streuli, MD PhD principal investigator
University Children's Hospital, Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Structured self-management-training in people with Muscular Dystrophies, run by University Children's Hospital, Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Orientation Questionnaire (HAKEMP) (time frame: 1 1/2 year with control group). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.