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    Multi-modal sleep intervention for community-dwelling people living with dementia and primary caregiver dyads with sleep disturbance: protocol of a single-arm feasibility trial
    (PeerJ Inc., 2023-01-01) Verma S; Varma P; Brown A; Bei B; Gibson R; Valenta T; Pietsch A; Cavuoto M; Woodward M; McCurry S; Jackson ML; Keogh J
    Background. Disturbed sleep is common among people living with dementia and their informal caregivers, and is associated with negative health outcomes. Dyadic, multi-modal interventions targeting caregiver and care-recipient sleep have been recommended yet remain limited. This protocol details the development of a singlearm feasibility trial of a multi-modal, therapist-led, six-week intervention targeting sleep disturbance in dyads of people living with dementia and their primary caregiver. Methods. We aim to recruit 24 co-residing, community-dwelling dyads of people living with dementia and their primary informal caregiver (n D 48) with sleep concerns (Pittsburgh Sleep Quality Index ≥5 for caregivers, and caregiver-endorsed sleep concerns for the person living with dementia). People who live in residential care settings, are employed in night shift work, or are diagnosed with current, severe mental health conditions or narcolepsy, will be excluded. Participants will wear an actigraph and complete sleep diaries for two weeks prior, and during the last two weeks, of active intervention. The intervention is therapist-led and includes a mix of weekly small group video sessions and personalised, dyadic sessions (up to 90 min each) over six weeks. Sessions are supported by a 37-page workbook offering strategies and spaces for reflections/notes. Primary feasibility outcomes are caregiver: session attendance, attrition, and self-reported project satisfaction. Secondary outcomes include dyadic self-reported and objectively-assessed sleep, depression and anxiety symptoms, quality of life, and social support. Self-report outcomes will be assessed at pre- and postintervention. Discussion. If feasible, this intervention could be tested in a larger randomised controlled trial to investigate its efficacy, and, upon further testing, may potentially represent a non-pharmacological approach to reduce sleep disturbance among people living with dementia and their caregivers.
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    "Nourish to Flourish": complementary feeding for a healthy infant gut microbiome-a non-randomised pilot feasibility study.
    (Springer Nature Limited., 2022-05-18) Lovell AL; Eriksen H; McKeen S; Mullaney J; Young W; Fraser K; Altermann E; Gasser O; Kussmann M; Roy NC; McNabb WC; Wall CR
    BACKGROUND: The introduction of complementary foods and changes in milk feeding result in modifications to gastrointestinal function. The interplay between indigestible carbohydrates, host physiology, and microbiome, and immune system development are areas of intense research relevant to early and later-life health. METHODS: This 6-month prospective non-randomised feasibility study was conducted in Auckland, New Zealand (NZ), in January 2018. Forty parents/caregivers and their infants were enrolled, with 30 infants allocated to receive a prebiotic NZ kūmara (flesh and skin; a type of sweet potato) prepared as a freeze-dried powder, and ten infants allocated to receive a commercially available probiotic control known to show relevant immune benefits (109 CFU Bifidobacterium lactis BB-12®). The primary outcome was the study feasibility measures which are reported here. RESULTS: Recruitment, participant retention, and data collection met feasibility targets. Some limitations to biological sample collection were encountered, with difficulties in obtaining sufficient plasma sample volumes for the proposed immune parameter analyses. Acceptability of the kūmara powder was met with no reported adverse events. CONCLUSION: This study indicates that recruiting infants before introducing complementary foods is feasible, with acceptable adherence to the food-based intervention. These results will inform the protocol of a full-scale randomised controlled trial (RCT) with adjustments to the collection of biological samples to examine the effect of a prebiotic food on the prevalence of respiratory tract infections during infancy. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12618000157279 . Prospectively registered on 02/01/2018.