Dataset Information

A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

ABSTRACT: Purpose. The purpose of this study was to assess the feasibility of the Spanish Diabetes Self-Management Program (SDSMP) in the primary care setting of the Basque Health Service and offer initial estimations of the randomized controlled trial (RCT) effects. Methods. Ten health centers (HCs) participated in a single-arm pilot study with a 6-month follow-up period between February 2011 and June 2012. Recruitment was performed via invitation letters, health professionals, and the local media. Each intervention group consisted of 8-15 people. The ability of each HC in forming up to 2 groups, participants' compliance with the course, and coordination and data collection issues were evaluated. Glycated haemoglobin (HbA1c) was the main outcome variable. Secondary outcomes were cardiovascular risk factors, drugs consumption, medical visits, quality of life, self-efficacy, physical exercise, and diet. Results. Two HCs did not organize a course. A total of 173 patients initiated the program, 2 dropped out without baseline data, and 90% completed it. No pre-post HbA1c differences existed. Certain improvements were observed in blood pressure control, self-efficacy, physical activity, and some dietary habits. Conclusion. The SDSMP is feasible in our setting. Our experience can be of interest when planning and conducting this program in similar health settings. The trial is registered with ClinicalTrials.gov identifier NCT01642394.

SUBMITTER: Gamboa Moreno E

PROVIDER: S-EPMC5227166 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

Gamboa Moreno Estibaliz E Ochoa de Retana Garcia Lourdes L Del Campo Pena Maria Emma ME Sánchez Perez Álvaro Á Martinez Carazo Catalina C Arbonies Ortiz Juan Carlos JC Rua Portu Maria Angeles MA Piñera Elorriaga Koldo K Zenarutzabeitia Pikatza Amaya A Urquiza Bengoa Miren Nekane MN Méndez Sanpedro Tomás T Oses Portu Ana A Gorostidi Fano Lourdes L Aguirre Sorondo Miren Bakarne MB Vrotsou Kalliopi K Rotaeche Del Campo Rafael R

Journal of diabetes research 20161229

<i>Purpose</i>. The purpose of this study was to assess the feasibility of the Spanish Diabetes Self-Management Program (SDSMP) in the primary care setting of the Basque Health Service and offer initial estimations of the randomized controlled trial (RCT) effects. <i>Methods</i>. Ten health centers (HCs) participated in a single-arm pilot study with a 6-month follow-up period between February 2011 and June 2012. Recruitment was performed via invitation letters, health professionals, and the loca ...[more]

PMID: 28119932

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Project description:ObjectiveTo improve the quality of peer leader training, this study developed a theory-based self-management training program for older adult peer leaders with diabetes and assessed its feasibility.BackgroundCurrent self-management programs are designed mainly to be implemented by healthcare professionals, but healthcare staff may not fully perceive the needs and obstacles of older adults in disease management due to a lack of similar illness experience. To target this problem, peer leaders with successful self-management experiences, similar cultural backgrounds and languages, and related illness experiences are trained to guide and mentor peer patients in self-management programs.Study design and methodsThis study was conducted in two stages. In stage 1, a peer leader training program was developed based on experiential learning theory as the framework and self-regulation theory as the activity design strategy. In stage 2, program feasibility was assessed via participants' feedback toward the training program by three indicators: attendance, future willingness to lead the peer-led self-management program, and leadership skills evaluated by a peer leader training assessment tool.ResultsIn this study, peer leaders demonstrated good leadership skills by expressing active willingness to lead self-management programs in the community. Peer leaders' feedback indicated that the program's training content was helpful in preparing peer leaders to guide older adults in learning self-management skills and in improving the abilities and confidence of peer leaders in mentoring self-management.ConclusionFindings in this study showed that peer leader training can impact the effectiveness and success of self-management in older adults with diabetes. Even in a small-scale study, the impact was evident, which demonstrated the feasibility of the program. More large-scale studies on the effectiveness of various peer leader training programs in diverse disciplines are recommended.Clinical trials registryClinicalTrials.gov Identifier: NCT04298424 (the Peer-Led Self-Management Program).

Project description:BACKGROUND:Mobile interventions hold promise as an intervention modality to engage children in improving diabetes self-management education, attitudes, and behaviors. OBJECTIVE:This pilot study aimed to explore the usability, acceptability, and feasibility of delivering a mobile diabetes educational tool to parent-child pairs in a clinical setting. METHODS:This mixed methods pilot study comprised two concurrent phases with differing study participants. Phase 1 used user testing interviews to collect qualitative data on the usability and acceptability of the tool. Phase 2 used a single-arm pre- and poststudy design to quantitatively evaluate the feasibility and preliminary efficacy of the intervention. Study participants (English-speaking families with youth aged 5-14 years with insulin-dependent diabetes) were recruited from an urban hospital in Massachusetts, United States. In phase 1, parent-child pairs were invited to complete the intervention together and participate in 90-min user testing interviews assessing the tool's usability and acceptability. Interview transcripts were analyzed using a directed content analysis approach. In phase 2, parent-child pairs were invited to complete the intervention together in the clinical setting. Measures included parental and child knowledge, attitudes, and behaviors related to diabetes management (self-report surveys) and child hemoglobin A1c levels (medical record extractions); data were collected at baseline and 1-month follow-up. Pre- and postoutcomes were compared using paired t tests and the Fisher exact test. RESULTS:A total of 11 parent-child pairs (N=22) participated in phase 1 of the study, and 10 parent-child pairs (N=20) participated in phase 2 of the study. Participants viewed the mobile educational tool as acceptable (high engagement and satisfaction with the layout, activities, and videos) and identified the areas of improvement for tool usability (duration, directions, and animation). CONCLUSIONS:The findings from this pilot study suggest that the mobile educational tool is an informative, engaging, and feasible way to deliver diabetes self-management education to parents and children in an urban hospital setting. Data will inform future iterations of this mobile diabetes educational intervention to improve usability and test intervention efficacy.

Project description:BackgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.MethodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.ResultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).ConclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.Trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.

Dataset Information

A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

Publications

A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

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