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Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis (PAIR-SEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05519553
Recruitment Status : Not yet recruiting
First Posted : August 29, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-remitting Other: Peer support Not Applicable

Detailed Description:

Multiple sclerosis (MS) is a debilitating and incurable chronic disease. Patients might benefit from peer support provided by patients entitled to give advice on daily life management with MS. Studies have shown that peer support can enhance chronic patients' quality of life in Psychiatry and Oncology.

This pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with MS, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind.

This mixed methods pilot study consists in a monocentric open-label randomized controlled trial. It is located in Nantes, France, and aims to recruit 60 patients with relapsing-remitting MS undergoing drug therapy from the Nantes University Hospital Neurology Department. Patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist).

Primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months.

Interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a mixed methods randomized controlled trial
Masking: None (Open Label)
Masking Description: non applicable
Primary Purpose: Other
Official Title: Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
30 MS (Multiple sclerosis, relapsing-remitting) patients
Other: Peer support
: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline
Other Name: non applicable

No Intervention: Control group
30 MS (Multiple sclerosis, relapsing-remitting) patients



Primary Outcome Measures :
  1. Therapeutic adherence [ Time Frame: 6 months ]

    Description : score difference at baseline and 6 months of the " Necessity " and " Concerns " subscales of BMQ-Specific (Beliefs about medicines questionnaire) compared between control and intervention groups.

    A score, between 5 and 25, is calculated for each subscale by making a sum of the answers. Next, score difference between Necessity and Concerns (NCF) is calculated. NCF varies between -20 and +20. Value above 0 means that perceived treatment necessity exceeds treatment associated concerns. The more NCF comes close to +20, the better is the treatment risk/benefit balance.



Secondary Outcome Measures :
  1. Therapeutic compliance [ Time Frame: 6 months ]

    score difference at baseline and 6 months of MARS (Medication Adherence Rating Scale) questionnaire compared between control and intervention groups.

    A final score, between 5 and 25, is calculated by making a sum of the answers. If final score is 21 or above, or if every item is scored at least 4 points, the patient is deemed compliant.


  2. Participants' quality of life [ Time Frame: 6 months ]

    score difference at baseline and 6 months of MusiQoL-MCAT (Multidimensional Computerized Adaptive Short-Form Quality of Life Questionnaire Developed and Validated for Multiple Sclerosis) compared between control and intervention groups.

    The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0 to 100 scale. A global index score is computed as the mean of the dimension scores. Higher scores indicate a higher level of quality of life.


  3. Emotional wellbeing [ Time Frame: 6 months ]

    score difference at baseline and 6 months of HAD (Hospital Anxiety and Depression) questionnaire compared between control and intervention groups.

    A final score, between 0 and 21, is calculated by making a sum of the answers for each subscale. A subscale score >8 denotes anxiety or depression. The higher the score is, the worse the severity of depression or anxiety symptoms.


  4. Social support [ Time Frame: 6 months ]

    score difference at baseline and 6 months of SSQ6 (Social Support Questionnaire) compared between control and intervention groups.

    Two scores are calculated by making a sum of the answers in each dimension: N score (availability) ranges from 0 to 54 and S score (satisfaction) ranges from 6 to 36. Higher scores indicate a higher level of support availability or satisfaction.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients
  • With relapsing-remitting MS according to 2017 revised Mc Donald criteria
  • Attending medical consultation at Nantes University Hospital Neurology Department
  • For whom background drug therapy is needed (oral or injectable)
  • Who gave consent to participate in trial

Exclusion Criteria:

  • Primary-progressive or secondary-progressive MS patients
  • Patients under protection of vulnerable adults measure or convicted
  • Patients not fluent in French
  • Patients with severe cognitive impairment, who may find difficult filling out questionnaires properly
  • Patients with a risk of follow-up interruption (move, nomadism…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519553


Contacts
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Contact: Leïla MORET, MD - PhD 02.40.84.69.24 ext 332 leila.moret@chu-nantes.fr
Contact: Lebeaupin Maxime 0253726305 ext +332 maxime.lebeaupin@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Director: Leïla Moret, MD - PhD CHU Nantes
Principal Investigator: Sandrine Wiertlewski, MD CHU Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT05519553    
Other Study ID Numbers: RC22_0175
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: non applicable

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
multiple sclerosis
peer support
therapeutic adherence
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases