A Personalized Reminder Information and Social Management System

Personalized Reminder Information and Social Management System - PRISM

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497613

Acronym

PRISM

Enrollment

300

Registered

2011-12-22

Start date

2011-02-28

Completion date

2014-05-31

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Isolation, Social Support (Formal and Informal), Well-being/Quality of Life

Keywords

Socialization, Well-being, Quality of Life, Connectivity

Brief summary

Although technology offers great potential for enhancing the health and well-being of older adults, robust studies are needed to quantify the value of technology and further the investigators understanding of barriers to technology access among older adults and of strategies that are effective in removing these barriers. This cross-site randomized field trial will evaluate a simple to use Personalized Reminder Information and Social Management System (PRISM) designed to support social connectivity, memory, skill building and resource access for older adults. The PRISM system (PRISM C condition) will be compared to an notebook information control condition (PRISM B condition). The target population is older adults who live at home alone and are at risk for isolation. The goal of the study is to gather systematic evidence about the value of technology for older adults and to identify factors that affect use and usability, acceptance and technology adoption. The investigators will also gather longitudinal data on the benefits of the system. Participants aged 65 - 85 years (100 per site) will be randomly assigned following baseline assessment to one of two conditions: PRISM C condition where participants receive the technology system or the PRISM B condition only control where participants receive a notebook that includes information similar to that provided in PRISM C (e.g., resource guide). The categories of information provided in the notebook is similar to the features provided on the system. Participants will include males and females who do not have a home computer and who have limited Internet experience. The intervention period is 12 months. A battery of measures that includes demographic information, attitudes towards technology (including computer self-efficacy and computer comfort), technology, computer and Internet experience, functional independence and well-being, emotional well-being social support/isolation, and quality of life will be administered at baseline, and 6 and 12 months post randomization. In addition, the investigators will assess cognitive abilities at baseline and twelve months. The investigators will also gather data regarding technology use and social interactions via a brief telephone interview at 18 months post randomization.

Interventions

BEHAVIORALPRISM C: Computer Condition

A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory

BEHAVIORALPRISM B: Notebook Condition

Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 65+ years * Live alone in the community in an independent residence * Minimum computer and Internet use in the past three months * English speaking * Able to read English at the 6th grade level * Has a telephone * 20/60 Vision with or without correction * Not employed or volunteering more than 5 hrs/week * Does not spend more than 10 hrs./week at a Senior Center or Formal organization * Planning to remain in the area in same living arrangements for duration of intervention period

Exclusion criteria

* Blind or deaf * Cognitively impaired (MMSE) \< 26 * Fuld Object Memory Test \< 20 or 19 * Terminal illness * Severe motor impairment

Design outcomes

Primary

Measure	Time frame	Description
Change in Social Isolation Measured by Friendship Scale	Baseline and 6th month	Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .
Change in Level of Social Support Measured by Social Support Scale	Baseline and 6th month	Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).
Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	Baseline and 6th month	Use the SF-36 scale to measure the overall well-being from baseline to 6th month follow-up. Higher score indicates more peaceful, happy, and calm. Range (0-100)

Secondary

Measure	Time frame	Description
Change in Computer Interest Measured by Computer Attitude - Interest Subscale	Baseline and 6th month follow-up	Use the computer attitude scale to measure the level of computer interest from baseline to 6th month follow-up. Higher score means more interest towards computer. Range (5-25)
Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .	baseline and 6 months	Use the computer attitude scale to measure the level of computer comfort from baseline to 6th month follow-up. Higher score means more computer comfort. Range (5-25).
Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale	Baseline and 6th month follow-up	Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)
Changes in Technology Proficiency Measured by Technology Proficiency Scale	baseline and 6 months	Measures the level of technology proficiency from baseline to 6th month follow-up. Higher scores means more computer proficiency. Range (6-30)
Change in Technology Adoption Measured by Technology Acceptance Questionnaire	baseline and 6 months	Measure the level of technology adoption from baseline to 6th month follow-up. Higher score means more acceptance. Range (6-42)

Countries

United States

Participant flow

Participants by arm

Arm	Count
PRISM B: Notebook Condition Telephone check-in calls and a notebook containing similar categories of information as the features on the PRISM C computer system such as a resource guide; games; classroom and information, calendar. PRISM B: Notebook Condition: Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.	150
PRISM C: Computer Condition A computer-based system designed to support socialization and access to resources; knowledge and prospective memory. The system is placed in the homes of those randomized to the condition for 12 months. PRISM C: Computer Condition: A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory	150
Total	300

Baseline characteristics

Characteristic	PRISM C: Computer Condition	PRISM B: Notebook Condition	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	150 Participants	150 Participants	300 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	76.97 years STANDARD_DEVIATION 7.3	75.34 years STANDARD_DEVIATION 7.4	76.15 years STANDARD_DEVIATION 7.4
Region of Enrollment United States	150 participants	150 participants	150 participants
Sex: Female, Male Female	119 Participants	115 Participants	234 Participants
Sex: Female, Male Male	31 Participants	35 Participants	66 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Change in Level of Social Support Measured by Social Support Scale

Measures the level of social support from baseline to 12th month follow-up. Higher score means more social support. Range (6-36).

Time frame: Baseline and 12th month

Population: Some participants did not complete the questionnaire

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change in Level of Social Support Measured by Social Support Scale	Baseline	24.90 units on a scale	Standard Deviation 6.9
PRISM B: Notebook Condition	Change in Level of Social Support Measured by Social Support Scale	12th month follow-up	25.66 units on a scale	Standard Deviation 7
PRISM C: Computer Condition	Change in Level of Social Support Measured by Social Support Scale	Baseline	25.33 units on a scale	Standard Deviation 6.9
PRISM C: Computer Condition	Change in Level of Social Support Measured by Social Support Scale	12th month follow-up	26.55 units on a scale	Standard Deviation 7.2

Primary

Change in Level of Social Support Measured by Social Support Scale

Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).

Time frame: Baseline and 6th month

Population: Some participants did not complete the questionnaire

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change in Level of Social Support Measured by Social Support Scale	Baseline	24.90 units on a scale	Standard Deviation 6.9
PRISM B: Notebook Condition	Change in Level of Social Support Measured by Social Support Scale	6th month follow-up	23.98 units on a scale	Standard Deviation 6.9
PRISM C: Computer Condition	Change in Level of Social Support Measured by Social Support Scale	Baseline	25.33 units on a scale	Standard Deviation 6.9
PRISM C: Computer Condition	Change in Level of Social Support Measured by Social Support Scale	6th month follow-up	26.12 units on a scale	Standard Deviation 7.2

Primary

Change in Social Isolation Measured by Friendship Scale

Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .

Time frame: Baseline and 6th month

Population: Some participants did not complete the questionnaire. 149 participants from PRISM B and 133 from PRISM C contributed to at least one of the two time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change in Social Isolation Measured by Friendship Scale	Baseline	18.75 units on a scale	Standard Deviation 4.1
PRISM B: Notebook Condition	Change in Social Isolation Measured by Friendship Scale	6th month follow-up	18.94 units on a scale	Standard Deviation 4.3
PRISM C: Computer Condition	Change in Social Isolation Measured by Friendship Scale	Baseline	19.72 units on a scale	Standard Deviation 3.7
PRISM C: Computer Condition	Change in Social Isolation Measured by Friendship Scale	6th month follow-up	20.27 units on a scale	Standard Deviation 3.7

Primary

Change in Social Isolation Measured by Friendship Scale

Measures the level of social isolation from baseline to 12th month follow-up. Lower score means less social isolation. Range (0-24) .

Time frame: Baseline and 12th month

Population: Some participants did not complete the questionnaire. 149 participants from PRISM B and 150 from PRISM C contributed to at least one of the two time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change in Social Isolation Measured by Friendship Scale	Baseline	18.75 units on a scale	Standard Deviation 4.1
PRISM B: Notebook Condition	Change in Social Isolation Measured by Friendship Scale	12th month follow-up	19.50 units on a scale	Standard Deviation 3.9
PRISM C: Computer Condition	Change in Social Isolation Measured by Friendship Scale	Baseline	19.72 units on a scale	Standard Deviation 3.7
PRISM C: Computer Condition	Change in Social Isolation Measured by Friendship Scale	12th month follow-up	20.24 units on a scale	Standard Deviation 3.6

Primary

Change Overall Well-being Measured by SF-36 Overall Well-being Subscale

Use the SF-36 scale to measure the overall well-being from baseline to 6th month follow-up. Higher score indicates more peaceful, happy, and calm. Range (0-100)

Time frame: Baseline and 6th month

Population: Some participants did not complete the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	Baseline	78.17 units in scale	Standard Deviation 16.1
PRISM B: Notebook Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	6th month follow-up	77.60 units in scale	Standard Deviation 18.2
PRISM C: Computer Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	Baseline	80.38 units in scale	Standard Deviation 18.2
PRISM C: Computer Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	6th month follow-up	82.12 units in scale	Standard Deviation 16.8

Primary

Change Overall Well-being Measured by SF-36 Overall Well-being Subscale

Use the SF-36 to measure the overall well-being from baseline to 12th month follow-up. Higher score means more peaceful, happy and calm. Range (0-100).

Time frame: Baseline and 12th month

Population: Some participants did not complete the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
PRISM B: Notebook Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	Baseline	78.17 units in scale	Standard Deviation 16.1
PRISM B: Notebook Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	12th month follow-up	75.78 units in scale	Standard Deviation 17.8
PRISM C: Computer Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	Baseline	80.38 units in scale	Standard Deviation 18.2
PRISM C: Computer Condition	Change Overall Well-being Measured by SF-36 Overall Well-being Subscale	12th month follow-up	76.43 units in scale	Standard Deviation 19.6

Secondary

Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .

Use the computer attitude scale to measure the level of computer comfort from baseline to 6th month follow-up. Higher score means more computer comfort. Range (5-25).

Time frame: baseline and 6 months