Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2024
INTERVENTION: The web‐based online intervention delivers psychoeducation, a peer forum, and incorporates various interactive components. Following the completion of baseline questionnaires, participants allocated to the intervention group will be granted continuous 24/7 access to the online intervention for a duration of 8 weeks. From the outset, participants will be encouraged to engage with the intervention for a minimum of one hour per week, with flexibility to select the content to their specific needs. Participants will receive support in utilising the intervention, including instructional information integrated within the programme, as well as access to assistance via the online coordinator's email. After the 16‐week trial period, the waitlist control group will be granted access to the website. Participants in the control group will have access for 8 weeks after their registration on the website. Randomisation will be performed after participants have provided informed consent and completed and returned the baseline questionnaire. Participants will be randomly allocated to either the online resource (website) or waitlist control arm, using a 2:1 ratio generated in the Statistical Package for Social Sciences (SPSS). The randomisation sequence was generated electronically by an independent statistician with no prior patient contact. The trial coordinator, who will maintain blinding until this stage, will then access the randomisation database to allocate participants into two groups. However, it's important to note that, given the nature of the intervention, neither the participants, the statistician, the research team, nor the website moderator will be able to remain blinded to the treatment allocation after randomisation. CONDITION: Supporting psychosocial and emotional well‐being and resilience in family members of people with inflammatory bowel disease (IBD) ; Digestive System PRIMARY OUTCOME: In this feasibility study, we will gauge the outcome by measures as outlined below:; 1. Recruitment: Recruitment will be quantitatively evaluated by tracking the following participant counts:; 1.1. Those expressing interest in taking part and sent Participant Information Sheet (PIS); 1.2. Participants asking further questions; 1.3. Participants who have provided their consent; 1.4. Participants who have been randomised into the study; ; 1.5. Additionally, we will provide a description, including sex, age, the relationship with the person with IBD, and the types of IBD, of the individuals who were excluded to assist in identifying possible future eligibility criteria. We will also actively seek reasons for non‐participation to gain insights into this aspect of the study. However, participants do not have to provide a reason for withdrawing if they do not wish to.; ; 2. Retention: We will assess retention by analysing the withdrawal rates during the intervention and by evaluating the rates of participants who furnish both baseline and follow‐up data. Additionally, we will inquire about the reasons behind participants declining to continue with the intervention or with the research. However, participants do not have to provide a reason for withdrawing if they do not wish to.; ; 3. The feasibility of using potential clinical outcomes: We will quantitatively evaluate this outcome by:; 3.1. Examining the completion rates for data collection forms involves assessing both the return of outcomes and identifying missing individual items. ; 3.2. Assessing the appropriateness and diversity of the data to serve as outcome measures for clinical effectiveness.; ; 4. Acceptance, adherence to and fidelity of the intervention will be assessed by:; 4.1. Analysing feedback, reflections, and insights shared by participants through exit interviews.; 4.2. Evaluate the competence in organising and moderating the website. ; 4.3. Analysing usage patterns (number and length of log‐ins); ; 5. To inform the process evaluation for the future definitive trial, we will:; 5.1. Assess the feasibility and challenges of scaling up the process evaluation to a larger study.; 5.2. Evaluate the acceptability and appropriateness of the interview process and identify any potential barriers to participation.; 5.3. Identify factors that may facilitate or hinder the successful implementation of the intervention in a larger study.; 5.4. Test and refine measures for assessing the reach, dose, and fidelity of the intervention.; ; Progression criteria:; The outcome measure relating to recruitment, retention, and adherence/fidelity will be assessed using Red‐Amber‐Green (RAG) criteria, which are defined as follows:; 1. Confirmation of adequate recruitment for a definitive trial. ; Go: 48 or more family members recruited over 4 months;; Review and consider revising: 30‐47 family members recruited over 4 months;; Stop: < 30 family members recruited over 4 months; 2. Confirmation of adequate retention for definitive trial; Go: 80% or more participants retained ; Review and consider revising: 65‐79% participants retained; Stop: < 65% participants retained; 3. Confirmation of adequate fidelity to the intervention; Go: 80% or more of participants in intervention group view information giving or engage blog sharing or peer group forum; 1 hour or more per week will be spent in the intervention. ; Review and consider revising: 50‐79 % of participants in intervention group read information giving or engage blog sharing or peer group forum; 30 mins‐1 hr per week will be spent in the intervention. ; Stop: < 50% of participants in intervention group read information giving or engage blog sharing or peer group forum; < 30 mins per week will be spent logged in to the intervention. ; ; The criteria for assessing the progress based on the data related to the completion of outcome measures will be evaluated using the following progression criteria.; Go: < 10% missing data in each completed questionnaire booklet and/or < 10% of questionnaires not returned at all; Review: > 10% missing data in each completed questionnaire booklet and/or >10% not returned at all SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Living with or have lived with an individual with IBD including parents, partner or spouse, child and siblings 2. Aged 16 years old or above 3. No IBD themselves 4. Able to write and speak in English so that you can understand the study information and the website. 5. Only one participant per family unit
Epistemonikos ID: 9cca767512686cadd3a40d758ddf7ddc7d19d2e9
First added on: Aug 28, 2024