TANDem-2:
Closing the gap to interventions for TAND
Overview
Welcome to the TANDem-2 project page! Here you will find an introduction to the aims of the project, including an overview of our methods.
Background
Many critical knowledge gaps remain in TAND research: we lack large-scale longitudinal data on the progression of TAND severity and its predictors, no research has investigated the relationship between caregiver wellbeing and TAND severity or explored whether caregiver wellbeing could be strengthened through targeted interventions. The TANDem-2 project aims to address these gaps and move closer to effective interventions for TAND.
Aims
- Aim 1: To map and model the longitudinal trajectories of TAND severity using the self-report quantified TAND Checklist (TAND-SQ) in 500 participants over the course of one year.
- Aim 2: To explore the relationship between caregiver wellbeing and TAND severity and its trajectories.
- Aim 3: To adapt and assess the feasibility and possible efficacy of a brief, innovative caregiver wellbeing intervention.
Methods
For aims 1 and 2, we plan to collect information on TAND severity, TAND interventions, and other demographic, TSC and wellbeing information from 500 particpants. These participants will be adult individuals with TSC, or adult caregivers of individuals with TSC of any age. We will ask participants to provide this information at 5 time points over 12 months via the TAND Toolkit App, which has been updated for longitudinal data collection.
Using the data provided, we will use a range of statistical techniques to identify distinct trajectories of TAND severity across the 12 months, and the predictors of these these different trajectories. We will explore the relationship between these trajectories and caregiver wellbeing.
For aim 3, we will adapt the ‘Well-Beans for Caregivers’ intervention using participatory methods within the TAND consortium. We will then conduct a small pilot trial of the intervention with three groups of caregivers. We will use descriptive and non-parametric statistics to determine the feasibility, acceptability and impact of the intervention on the wellbeing of caregivers.
Potential impact
We are hoping that the information generated in this study will help to inform all potential TAND intervention studies by bringing understanding how TAND severity changes naturally over time. We will also be able to determine the utility of the TAND-SQ as a treatment outcome measure. We also hope that the study will shine a spotlight on caregiver wellbeing in TSC and provide preliminary evidence of a scaleable online caregiver intervention for a larger clinical trial, thus offering an accessible tool to support families affected by TAND.
Funding
This project is funded by the TSC Alliance and the Department of Defense (DoD) Tuberous Sclerosis Complex Research Program (TSCRP): Funding Opportunity Number HT9425-23-TSCRP-CTRA and award numbers HT94252410790 and HT94252410791.
Ethics
The project has received ethical clearance from Vrije Universiteit Brussels (EC-2024-222), University of Cape Town (327/2024), and the DoD Office of Human Research Oversight (OHRO) (E05445.1a).
