Improving Outcomes of Older Adults Undergoing Ostomy Surgery
ConditionOstomy - Ileostomy or Colostomy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The goal of this pilot study is to learn if an intervention in patients undergoing ostomy surgery is easy to use. The overall goal of the work is to improve quality of life during recovery in the days after surgery for these patients using the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients Age 65+ years
clinicians age 18+ years
Patients undergoing fecal ostomy surgery and their clinicians
Disqualifiers
cognitive impairment not allowing completion of consent procedures based on the teach-back method.
Trial design
Design model
Single group
Treatments tested in this trial
Geriatric Assessment Strategy for Ostomy Management and Adaptation (GA-STOMA)
BehavioralThe web-based intervention provides patients with a survey and tailored content with the purpose of better supporting recovery and adaptation after surgery with a fecal ostomy
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: GA-STOMAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability
Interviews will be performed to assess the ability to use the intervention, complete questions, obtain management recommendations and complete management recommendations.
Time frame
6 weeksSecondary outcomes
1
Client Satisfaction questionnaire
This is a quantitative evaluation of intervention acceptability
Time frame
6 weeks after surgery dateSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov