SMART-program:Dual Sensory-Stimulation for Relieving Feeding Difficulty and Triggering Oral Intake Among People With Dementia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dementia Feeding Difficulty Cues
研究概览
简要总结
Feeding difficulties are a common issue among individuals with dementia during moderate to advanced stages, particularly those in long-term care (LTC) facilities. Due to severe cognitive and communicative impairment, these residents often have a high dependency on feeding assistance. Consequently, caregivers manage not only refusal to eat and prolonged mealtimes but also the resulting nutritional problems among these patients. The eating process includes the anticipatory phase, during which food is identified via sensory triggers, thereby stimulating saliva secretion. This process facilitates bolus formation and ensures a smooth transition to the swallowing phase. Accordingly, this study aims to investigate the efficacy of a dual-sensory intervention, combining salivary gland massage and olfactory stimulation, in improving feeding difficulties and food intake among individuals with moderate-to-severe dementia.
This study will employ a randomized controlled trial (RCT) design. The experimental group will receive an intervention comprising salivary gland massage combined with aromatherapy for a total of 20 days. Simultaneously, baseline characteristics, including sociodemographic data, health status, and oral moisture, will be collected. Data for the 'Dementia Mealtime Nonverbal Cues' and two-meal intake will be monitored daily on weekdays for two weeks; all other variables will be assessed once. During the intervention period, the experimental procedure will be performed twice daily, prior to lunch and dinner. The control group will receive only a palm massage prior to meals. Throughout the intervention, participants will be assessed for "The Dementia Mealtime Nonverbal Cues" and oral intake during lunch and dinner every weekday. Additionally, oral moisture will be evaluated once weekly (T1-T4). Data will be analyzed using Linear Mixed Models (LMM) to examine the differences and longitudinal changes in outcome measures between the two groups. The findings of this study will contribute to the establishment of a safe, feasible, and culturally appropriate feeding care model for institutionalized individuals with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resided in a long-term care (LTC) facility for more than three months.
- •Diagnosed with any type of dementia, with either a Clinical Dementia Rating (CDR) of 2 or higher, a Mini-Mental State Examination (MMSE) score below 20, or a Short Portable Mental Status Questionnaire (SPMSQ) score greater than or equal to 3 errors (indicating moderate to severe impairment).
- •A feeding item score of below 5 on the Barthel Index (indicating the participant needs assistance with cutting food, spreading butter, etc., or requires a modified diet or is unable to feed themselves). DOCX
排除标准
- •Absence of observable expression, behavioral, or response to olfactory stimuli.
- •Current use of a nasogastric tube (NG tube) or a percutaneous endoscopic gastrostomy (PEG).
- •Diagnosis of hyperphagia or pica.
- •Inability to cooperate with the required salivary gland massage.
- •Uncontrolled epilepsy, severe or unstable cardiovascular disease, severe asthma, severe chronic obstructive pulmonary disease (COPD), or gastrointestinal bleeding.
- •Known allergy to essential oils.
- •Undergone surgery related to oral, tongue, or thyroid cancer.
结局指标
主要结局
Dementia Feeding Difficulty Cues
时间窗: Every lunch and dinner from baseline up to 6 weeks
Feeding difficulty is assessed using the unabbreviated scale title: Dementia Mealtime Nonverbal Cues checklist. This adapted checklist consists of 21 items categorized into negative behaviors (chewing/swallowing difficulty and resistive behaviors; 16 items) and positive/neutral behaviors (5 items). Assuming each item is scored as Yes=1 and No=0, the minimum score is 0 and the maximum is 16 for negative behaviors, where higher scores indicate worse feeding difficulties. For positive behaviors, the score ranges from 0 to 5, where higher scores indicate better feeding performance.
次要结局
- Oral Intake(Every lunch and dinner from baseline up to 6 weeks)
- Duration(Every lunch and dinner from baseline up to 6 weeks)
- Oral moisture(Once weekly from baseline up to 6 weeks)
- Body weight(Baseline, Week 4 (end of intervention), Week 8 (1 month post-intervention))
研究者
Shu-Ying Li
PhD candidate
National Cheng Kung University
