NCT06246058

Brief Summary

The primary research objective is to examine how uncertainty towards a new medical treatment changes in patients when a partner (can be any close other, i.e. romantic partner, family member, or a close friend) supports the new treatment choice and is willing to be involved in the patient's treatment. I hypothesize that when the patients know that their partner supports uptake of the new medical treatment and will physically accompany them to the visit, patients will (1) experience lower levels of uncertainty and (2) report a higher likelihood of participating in a new treatment in the future, as compared to patients who face the decision about the new treatment alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

January 8, 2024

Last Update Submit

November 15, 2024

Conditions

Keywords

Social supportUncertaintyLow-resource settingAmbiguity aversionBehavioral economicsResearch administrationRecruitment success

Outcome Measures

Primary Outcomes (1)

  • AA-Med score

    Ambiguity aversion score difference between two survey groups; AA-Med contains 6 response items, each scored from 1 to 4 (1=disagree completely; 4=agree completely)

    1 time measurement immediately after intervention

Secondary Outcomes (1)

  • Recruitment rate

    1 time measurement immediately after intervention

Study Arms (4)

Survey Group 1 - Support

Receives a vignette with partner support component before answering AA-Med response items.

Behavioral: Partner support

Survey Group 2 - Control

Receives a vignette without partner support component before answering AA-Med response items.

Behavioral: Without Partner support

Recruitment Group 1 - Casual

Recruited by staff wearing casual attire.

Behavioral: Casual recruiter attire

Recruitment Group 2 - Formal

Recruited by staff wearing formal (clinical) attire

Behavioral: Formal recruiter attire

Interventions

Partner supportBEHAVIORAL

The intervention group's survey vignette will include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Survey Group 1 - Support

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed. FORMAL dress code of the recruiter is the intervention in this case, defined as clinical attire alluding to some clinical authority.

Recruitment Group 2 - Formal

The intervention group's survey vignette will NOT include a component of partner support which serves as the key behavioral manipulation tested for this study's primary outcome.

Survey Group 2 - Control

The SWAT will separately test recruitment rates - as measured by rate of survey completion divided by total number of individuals approached - based on how the recruiters are dressed. CASUAL dress code of the recruiter is the intervention in this case.

Recruitment Group 1 - Casual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recruitment will occur in the Butha Buthe district hospital and health centers in the Butha Buthe district.

You may qualify if:

  • Adults over 18 years of age
  • Are comfortable reading and writing in Sesotho or English
  • Attending as a patient in Butha Buthe-area hospital or health center for a known clinical diagnosis or standard health screening related to one of these illness categories:
  • HIV
  • Other sexually-transmitted infection (i.e. gonorrhea, syphilis, hepatitis)
  • Breathing problem/ tuberculosis
  • Heart issues/ blood pressure
  • Diabetes/ sugar level
  • Bone/ muscle problem
  • Mental health
  • Memory/ thinking problem
  • Teeth/ mouth problem
  • Cancer
  • Maternal health (i.e. pregnancy, post-partum care)

You may not qualify if:

  • Have participated in this study before
  • Visible intoxication and/or distress, as deemed by trained research assistant
  • Unable to make independent decisions; unable to complete informed consent
  • Warrants emergency medical care
  • Visiting the hospital for another person (i.e. their child, relative, partner)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butha Buthe Government Hospital

Butha-Buthe, Lesotho

Location

Related Publications (1)

  • Han PK, Reeve BB, Moser RP, Klein WM. Aversion to ambiguity regarding medical tests and treatments: measurement, prevalence, and relationship to sociodemographic factors. J Health Commun. 2009 Sep;14(6):556-72. doi: 10.1080/10810730903089630.

    PMID: 19731127BACKGROUND

Related Links

MeSH Terms

Conditions

Health BehaviorPatient Acceptance of Health CareConsumer BehaviorSocial Behavior

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and Compliance

Study Officials

  • Grace H Yoon, MSc

    University Hospital Basel, University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

February 7, 2024

Study Start

February 15, 2024

Primary Completion

September 13, 2024

Study Completion

September 13, 2024

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest. Data shared will be completely anonymized. Study components, aggregate data and results will be disseminated on OSF. Any additional data sharing is subject to approval of the request and execution of all applicable agreements (i.e. a material transfer agreement).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Starting six months after completion of data collection for up to 24 months thereafter.
Access Criteria
Independent researchers with academic interest.
More information

Locations