18 and older, any sex, with Blood Donors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Donation AttemptPrimary· 6 Months and 34 days
Blood donation attempt at any time during follow-up. The planned follow-up (i.e., final assessment) was at 6-months and 2 weeks from randomization. However, the local protocol IRB approval lapsed between 25 April 2022 and 23 May 2022 during which time participants were unable to receive WhatsApp messaging. In response, the final follow-up window was extended by 34 days for all participants, so the participants in the WhatsApp arm would receive all planned messages.
Group
Value
95% CI
FRD: Control
2
VNRBD: Control
2
FRD:WhatsApp
2
VNRBD: WhatsApp
7
Docudrama
0
Sponsor's own description
DESIGN This pilot study utilizes a mixed-methods approach to develop a novel docu- drama communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger pragmatic randomized controlled trial (RCT) of the two communication strategies and assess acceptability of the communication strategies aimed to increase blood donation among first-time blood donors within the catchment areas of the Southern Zonal Blood Centre (SZBC) in Ghana. In sequence, this pilot study and larger RCT are grounded in the PRECEDE-PROCEED implementation science framework. The pilot study has four components: 1) a qualitative component will be used to design a docu-drama, 2) key informant interviews to guide intervention development, 3) a simultaneous randomized pilot trial will evaluate the feasibility of the larger trial design of communication interventions using WhatsApp compared to control, and 4) a final mixed- methods (quantitative survey and focus groups) assessment of participant views of acceptability, effectiveness, feasibility and cultural appropriateness of the two proposed communication interventions.
OBJECTIVES The three objectives of this pilot study are the careful design of a novel docu- drama communication intervention and WhatsApp intervention, evaluation of the feasibility of a larger RCT of communication strategies, and assessment of participant views of the two proposed communication interventions and control among first time blood donors within the catchment areas of the SZBC.
For the purposes of registration for clinicaltrials.gov only the randomized pilot trial communication interventions using WhatsApp compared to control is reported.
The planned sample size for the pilot RCT is n=128 first-time blood donors.
The study population for the pilot RCT is first-time voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors (FRD) from the SZBC catchment area.
REGIMEN WhatsApp: Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.
Control: Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 10 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04783077.