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临床试验/NCT05032872
NCT05032872已完成不适用

Social Exergame Intervention to Promote Physical Activity, Social Support, And Well-Being in Family Caregivers

Brandeis University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Social Connectedness Scale

研究概览

简要总结

The goal of this study is to examine Go&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

详细描述

The study is a 2-week baseline and 6-week intervention aimed at comparing the feasibility and efficacy of an exergame (Go&Grow without social contact components) and a social exergame (full version of Go&Grow) in promoting physical activity, social support, and well-being in family caregivers. The study also seeks to test social support and physical activity as mechanisms for the relationships between condition (exergame non-social vs social exergame) and wellbeing. Participants will be randomly assigned using a random assignment generator to either the control condition (exergame non-social) or the treatment condition (social exergame) on a rolling basis. Participants from both conditions will be reminded daily via app-based notifications during the intervention period to wear their Fitbit and to play the game.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who are caregivers for a family member (e.g., relative, spouse, friend) who is 65 years or older and is either frail, has a disability, or has at least one chronic illness
  • 40 years or older
  • Own an Android smartphone with Google play store/internet access
  • Able to walk for at least 20 minutes at a time
  • Comfortable wearing a fitness tracker for the duration of the study
  • Familiar with smartphone app usages
  • Comfortable with using the study-related app for the duration of the study

排除标准

  • Had a recent (within the past 6 months) cardiovascular event or fall.
  • Currently participating in any other physical activity study/intervention
  • Currently own or use a Fitbit or other activity tracking watches
  • Knows someone who is participating or has participated in the study
  • Currently physically active (exercise regularly 3 times a week or more for at least 30 minutes)
  • More than 2 errors on the Short Portable Mental Status Questionnaire (Pfeiffer, 1975).

结局指标

主要结局

Social Connectedness Scale

时间窗: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

Social Connectedness Scale was administered weekly during the intervention with the following subscales: relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity and quality, and dissatisfaction with contact quantity. Scores were averaged across items from each subscale and possible scores ranged from 1 to 7 with higher scores indicating a higher level of the subscale.

Perceived Stress Scale (PSS)

时间窗: Pretest (before week 1) and posttest (after week 8)

Perceived Stress Scale (PSS) asks participants' stress perception over the last month and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).

Brief Symptom Inventory (BSI)

时间窗: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8

Brief Symptom Inventory (BSI) captures participants' psychological distress over the past week, scores were summed across the items (Total score ranges from 0-72, with higher scores indicating more stress) (Derogatis, 1975).

Caregiver's Stress Scale

时间窗: Pretest (before week 1) and posttest (after week 8)

Caregiver's Stress Scale has a series of subscales based on a conceptual model of caregivers' stress: overload, relational deprivation, job and caregiving conflict, role captivity, sense of self, caregiving competence, personal gain, management of situation, management of meaning, management of distress, and expressive support. Each subscale ranges from 1 (strongly disagree) to 4 (strongly agree), and each subscale was averaged (with possible score ranging from 1-4) so that higher scores would indicate a higher value.

International Physical Activity Questionnaire (IPAQ) Short Version

时间窗: Pretest (before week 1) and posttest (after week 8)

International Physical Activity Questionnaire - Short Version. A continuous score was calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs\*min\*days) + (Mod METs\*min\*days) + Vig METs\*min\*days). A higher score means a higher level of physical activity.

Percent Change in Steps

时间窗: Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8

Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step. Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps.

Lubben Social Network Scale (LSNS)

时间窗: Pretest (before week 1) and posttest (after week 8)

Self-report measure of social support from the Lubben Social Network Scale for family and friends with scores summed across 18 items. Possible scores range from 0-60, with higher scores indicating higher social support.

UCLA Loneliness Scale

时间窗: Pretest (before week 1) and posttest (after week 8)

The UCLA Loneliness Scale captures one's subjective feelings of loneliness over the past week for weekly surveys and over the past month for pretest and posttest surveys (20 items with ratings from 1 "Never" to 4 "Often"). The scores were averaged across the 20 items, with a score ranging from 1-4. A higher score indicates more loneliness.

Positive and Negative Affect Schedule (PANAS) (20 Items)

时间窗: Pretest (before week 1) and posttest (after week 8)

Positive and Negative Affect Schedule (PANAS) (20 items) asks participants to report how often participants felt positive and negative feelings over the past week for weekly surveys, and over the past month for pre-test and post-test surveys. Scores were averaged across the items (Total positive and negative affect scores can range from 0-4, with a higher score indicating a higher level of positive affect or negative affect).

次要结局

  • Sense of Control(Pretest (before week 1) and posttest (after week 8))
  • Exergame Enjoyment Questionnaire (EEQ)(Posttest (after week 8))
  • Satisfaction With Life Scale(Pretest (before week 1) and posttest (after week 8))
  • Exercise Self-Efficacy(Pretest (before week 1) and posttest (after week 8))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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