Dataset Information

Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial.

ABSTRACT: Food-related quality of life (FR-QoL) is impaired in inflammatory bowel disease (IBD) and education and support on food-related issues in IBD is needed. This feasibility trial aimed to investigate the effectiveness and acceptability of a web resource in enhancing FR-QoL in newly diagnosed IBD. Patients diagnosed with Crohn's disease or ulcerative colitis in the preceding 12 months, with an impaired FR-QoL, were recruited and randomised to either receive access to the web resource (covering IBD-specific diet concerns) or no access (control group) for 12 weeks, while receiving usual clinical care. FR-QoL, health-related quality of life, psychological outcomes, and clinical disease activity were assessed. Web resource usage was assessed, and patients' experiences of the web resource were investigated in semi-structured interviews. Of 81 patients screened, 50 participants were randomised, 30 to the web resource and 20 to control. FR-QoL increased more in the web resource (+11.7 SD 18.2) than control group (+1.4 SD 20.4) (p = 0.067), while IBD distress reduced in the web resource (-6.8 SD 26.6) and increased in the control group (+8.3 SD 25.5) (p = 0.052), albeit not statistically significantly. End of trial Crohn's disease clinical activity (PRO-2) was significantly lower in the web resource than control group (p = 0.046). Participants most frequently accessed web resource content discussing dietary management of gut symptoms and in semi-structured interviews, reported the website to contain relevant information. This feasibility study demonstrates potential effectiveness of the web resource on improving FR-QoL and psychological outcomes in IBD. An adequately powered effectiveness RCT is feasible to conduct and is now warranted. NCT03884686.

SUBMITTER: Cox SR

PROVIDER: S-EPMC9611328 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial.

Cox Selina R SR Czuber-Dochan Wladyslawa W Wall Catherine L CL Clarke Hazel H Drysdale Candice C Lomer Miranda C MC Lindsay James O JO Whelan Kevin K

Nutrients 20221014 20

Food-related quality of life (FR-QoL) is impaired in inflammatory bowel disease (IBD) and education and support on food-related issues in IBD is needed. This feasibility trial aimed to investigate the effectiveness and acceptability of a web resource in enhancing FR-QoL in newly diagnosed IBD. Patients diagnosed with Crohn's disease or ulcerative colitis in the preceding 12 months, with an impaired FR-QoL, were recruited and randomised to either receive access to the web resource (covering IBD-s ...[more]

PMID: 36296976

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Project description:BackgroundThe reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking.ObjectiveWe aimed to evaluate the impact of remote monitoring using a Web system-Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU)-as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD.MethodsWe performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G_TECCU), nurse-assisted telephone care (G_NT), or standard care with in-person visits (G_control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected.ResultsA total of 63 patients were selected (21 patients in each group). During the study, 90.5% (19/21) of patients in G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 71.4%). A higher improvement in disease activity was observed in G_TECCU than in G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G_TECCU compared to G_control (estimated intervention effect: odds ratio=-0.90; 95% CI=-1.96 to 0.16, P=.11). All completers adhered to treatment in G_TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G_TECCU than in G_NT and G_control, the safety profile was similar in all 3 groups.ConclusionsThis pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources.Trial registrationClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN).

Project description:BackgroundEvidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.MethodsThis study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12 months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.ResultsFifty one participants were recruited over 12 months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.ConclusionsA Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.Trial registrationClinicalTrials.gov: NCT02791048 . Registered 6 June 2016.

Project description:BackgroundFatigue is the third most prevalent symptom for patients with inflammatory bowel disease (IBD), yet optimal strategies for its management are unclear. Treatment protocols for fatigue in other conditions have been based on cognitive-behavioural models. Targeting cognitions, emotions and behaviour related to fatigue through cognitive-behavioural therapy (CBT) may be a viable option to improve fatigue and quality of life (QoL) in IBD.MethodsThis single centre, two-arm, feasibility randomised controlled trial (RCT) aimed to assess the feasibility and initial estimates of potential efficacy of a CBT intervention for the management of IBD-fatigue. Feasibility, acceptability and initial estimates of potential efficacy outcomes were collected through self-report measures and semi-structured interviews. Participants were recruited from one tertiary referral centre. Intervention Group 1 received a CBT manual for fatigue, one 60-min and seven 30-min telephone sessions with a therapist over 8-weeks. Control Group 2 received a fatigue information sheet without therapist support. A nested qualitative study evaluated patients' and therapists' experiences, and IBD-healthcare professionals' (HCPs) perceptions of the intervention.ResultsEighty-nine participants were assessed for eligibility. Of these, 31 of the 70 eligible participants consented to participate (recruitment rate of 44%). Of the 15 participants randomised to the intervention group, 13 (87%) started it and 10 (77% of those who started) completed all 8 sessions. Follow-up questionnaires were completed by 22 (71%) participants at 3 months, 14 (45%) at 6 months and 12 (39%) at 12 months' follow-up. The intervention was acceptable to participants and feasible for therapists to deliver. HCPs reported that the intervention would be applicable, but time, finance and training constraints limit its implementation. Initial estimates of potential efficacy with complete case analysis showed a reduction in fatigue and an increase in QoL at 3, 6 and 12 months post-randomisation.ConclusionsA full-scale effectiveness RCT testing CBT for IBD-fatigue is feasible and is potentially worthwhile with some changes to the protocol. However, given the small numbers, further pilot work is warranted before a full-scale RCT.Trial registrationRegistration Trial ISRCTN 17917944, Registered 2 September 2016.

Dataset Information

Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial.

Publications

Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial.

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