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临床试验/NCT04026061
NCT04026061已完成不适用

Randomised Controlled Feasibility Study Into FindMyApps; First Evaluation of a Tablet Intervention to Promote Self-management and Meaningful Activities in People With Mild Dementia

Saxion University of Applied Sciences2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Self-management abilities people with dementia

研究概览

简要总结

First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

详细描述

Testing the feasibility and mechanism of impact of FindMyApps, a tablet intervention consisting of a selection tool to help persons with dementia find usable apps for self-management and meaningful activities and a training that supports informal carers to employ errorless learning principles to help people with dementia to learn how to use the tablet and the tool.

An exploratory pilot randomized controlled trial was carried out with a mixed-methods design. Twenty persons with mild dementia and carer dyads were randomly assigned to the FindMyApps group (n = 10) that used the FindMyApps training and selection tool, or a control condition that just got a tablet (n = 10). After informal carers had received the training, the dyads in the experimental group started with the three-month intervention. Pre and post-test measurements consisted of questionnaires and post-test semi-structured interviews.

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
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible dyads had to be community dwelling.
  • Persons with dementia had Mild Cognitive Impairment or mild dementia with a score of 3 to 4 on the Global Deterioration Scale (GDS; 45), with or without a confirmed diagnosis.
  • Availability of an informal carer or volunteer to provide support.

排除标准

  • Participation in another intervention trial
  • Severe visual and/or physical impairment.

研究组 & 干预措施

FMA group

Experimental

Receiving the FMA training and tool

干预措施: FMA group (Behavioral)

control group

Placebo Comparator

Receiving a simple tablet training and some websites

干预措施: Control group (Behavioral)

结局指标

主要结局

Self-management abilities people with dementia

时间窗: At baseline and post-intervention at 3 months follow up

Measured with the revised 30-item Self-Management Ability Scale (SMAS-30). Change/ difference between baseline and post-intervention. It consists of six subscales: Taking Initiative, Self-efficacy, Investing, Positive Perspective, Multifunctionality, and Variety. Each subscale consists of five items scored on a 5-point or 6-point Likert-type scale. A 5-point scale is used for 'Self-efficacy' (1 = I certainly do not think so, 5 = I certainly think so) and 'Positive Perspective' (1 = No!, 5 = Yes!), and a 6-point scale is used for 'Taking Initiative', 'Investing', and 'Multifunctionality' (1 = never, 6 = very often), and 'Variety' (1 = none, 6 = more than six). Item scores are transformed into scores ranging from 0 to 20. Mean subscale scores range from 0 to 100, as does the total score, which is the mean score of the six subscales. A higher score indicates more self-management abilities.

Feeling of competence informal carers

时间窗: At baseline and post-intervention at 3 months follow up

Measured with the Short Sense of Competence Scale (SSCQ). Change/ difference between baseline and post-intervention.The SSCQ contains of seven statements. Informal caregivers had answered these questions on a 5-point-likert scale which ranges from 'agree very strongly' to 'disagree very strongly'. For feeling of competence, the scores on all items were summed to get a sum-score. The sum-score ranges between 7 and 35 and a higher score indicates a greater feeling of competence.

Participation in daily and social activities people with dementia

时间窗: At baseline and post-intervention at 3 months follow up

Measured with a short version of the Pleasant Activities List (PAL). Change/ difference between baseline and post-intervention. The PAL was used to assess the frequency and enjoyability of daily and social activities. In this study, the PAL was shortened from its original 139 item to 31 items divided into two subscales: Social Activities (SA), such as visiting family, and Domestic Activities (DA), such as gardening. Shortening was done for two reasons: the length of the original version was thought to be not feasible for the PwDs and a focus on social and domestic activities was more in line with this study. Items relate to the frequency of engagement and the subjective enjoyability, which are scored on a 5-point Likert-type scale ranging from 1 (not at all) to 5 (very much). A higher score indicates that activities are done more often and enjoyed more.

次要结局

  • Perceived autonomy people with dementia(At baseline and post-intervention at 3 months follow up)
  • Perceived self-efficacy people with dementia(At baseline and post-intervention at 3 months follow up)
  • Quality of life people with dementia(At baseline and post-intervention at 3 months follow up)
  • Positive care experiences informal carers(At baseline and post-intervention at 3 months follow up)
  • Quality of life informal carers(At baseline and post-intervention at 3 months follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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