Fistula Reintegration Pilot
|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: NCT04748653|
Recruitment Status : Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Female Genital Fistula Urinary Incontinence||Behavioral: Multi-component reintegration intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comprehensive Reintegration Assistance for Women With Obstetric Fistula|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Multi-component reintegration intervention
There is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment.
Behavioral: Multi-component reintegration intervention
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
- Proportion of planned intervention sessions that were delivered [ Time Frame: 6 weeks ]Number of participants who received each planned intervention session over the total number of participants enrolled.
- Proportion of participants indicating satisfied or very satisfied with the intervention. [ Time Frame: 6 weeks ]Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience with each intervention module on a five-point Likert scale at six weeks over the total number of participants completing each module.
- Change in reintegration score [ Time Frame: Baseline and 6 months ]Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better)
- Change in quality of life [ Time Frame: Baseline and 6 months ]Mean change in quality of life score from pre-intervention (baseline) to post (6 months) on the WHO QOL-BREF measure (range 0-100, higher indicating better)
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): NCT04748653
|Contact: Alison El Ayadi, ScD, MPHfirstname.lastname@example.org|
|Contact: Abner Kornemail@example.com|
|Principal Investigator:||Alison El Ayadi, ScD, MPH||University of California, San Francisco|