Contemporary clinical trials · 2019
Study protocol and baseline sample characteristics: From clinic to community: Using peer support as a transition model for improving long-term diabetes-related health outcomes.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Tang Tricia S, Afshar Rowshanak, Elliott Thomas, Kong Jason, Gill Sabrina
Аннотация
BACKGROUND: The objective of this randomized controlled trial is to examine the effects of a 12-month telephone-based peer-led diabetes self-management support (DSMS) intervention on long-term diabetes-related health outcomes.
METHODS: In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care. The primary clinical and psychosocial outcomes were HbA1c and diabetes distress (DD), respectively. Secondary outcomes were cardiovascular risk factors. Assessments were conducted at baseline, 3 months, and 12 months.
RESULT: Of 197 recruited participants, 49.7% were female. The majority of participants were married/partnered, well-educated, employed, and Caucasian, with a mean HbA1c of 8.09 ± 1.7. Forty-two percent of participants reported little or no distress. There was no significant difference between the two groups.
DISCUSSION: Despite evidence showing that individuals with poor glycemic control benefit the most from peer support interventions, the majority of such interventions have been designed for and implemented in community and primary care-based settings. The present study investigates a 12-month peer support model to help patients initiate and sustain effective self-management behaviors while transitioning from specialty care to a community setting. The study was completed in November 2018. The outcome data analyses are currently underway.
TRIAL REGISTRATION: The study was registered on clinicaltrials.gov (NT02804620).
PROTOCOL VERSION: The protocol version is 3.5.
METHODS: In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care. The primary clinical and psychosocial outcomes were HbA1c and diabetes distress (DD), respectively. Secondary outcomes were cardiovascular risk factors. Assessments were conducted at baseline, 3 months, and 12 months.
RESULT: Of 197 recruited participants, 49.7% were female. The majority of participants were married/partnered, well-educated, employed, and Caucasian, with a mean HbA1c of 8.09 ± 1.7. Forty-two percent of participants reported little or no distress. There was no significant difference between the two groups.
DISCUSSION: Despite evidence showing that individuals with poor glycemic control benefit the most from peer support interventions, the majority of such interventions have been designed for and implemented in community and primary care-based settings. The present study investigates a 12-month peer support model to help patients initiate and sustain effective self-management behaviors while transitioning from specialty care to a community setting. The study was completed in November 2018. The outcome data analyses are currently underway.
TRIAL REGISTRATION: The study was registered on clinicaltrials.gov (NT02804620).
PROTOCOL VERSION: The protocol version is 3.5.
Предметные рубрики MeSH
AgedFemaleHumansMaleMiddle AgedApolipoproteins BBlood PressureCardiovascular DiseasesCounselingDepressionDiabetes Mellitus, Type 2DietGlycated HemoglobinHealth BehaviorPeer GroupResearch DesignSelf CareSocial SupportSocioeconomic FactorsStress, PsychologicalTelephoneMulticenter Studies as TopicRandomized Controlled Trials as Topic