Trial Outcomes & Findings for Fistula Reintegration Pilot (NCT NCT04748653)

Results Overview

Number of planned intervention session over the total number of planned interention sessions

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fistula Reintegration Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	34.5 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of planned intervention session over the total number of planned interention sessions

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Percentage of Planned Intervention Sessions That Were Delivered	96.2 percentage of planned sessions Interval 95.0 to 97.5

PRIMARY outcome

Timeframe: 6 weeks

Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.	12 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Change in Reintegration Score	30.5 scores on a scale Interval 23.5 to 39.5

SECONDARY outcome

Timeframe: 6 weeks

Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants.

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants	12 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants.

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.	12 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of participants reporting to be "satisfied" or "very satisfied" about their experience with the physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants.

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.	12 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants

Outcome measures

Outcome measures
Measure	Multi-component Reintegration Intervention n=12 Participants 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants	12 Participants

Adverse Events

Multi-component Reintegration Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alison El Ayadi, Associate Professor

University of California San Francisco

Phone: 415-476-5877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place