Producing a Fully Asynchronous Online Savvy Program

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04951037

Enrollment

Registered

2021-07-06

Start date

2021-09-15

Completion date

2022-09-02

Last updated

2024-04-16

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

Conditions

Dementia

Keywords

Dementia caregiver

Brief summary

This is a pilot/feasibility study to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD).

Detailed description

This study seeks to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD). As the number of PLWD rises in the United States from the perhaps 7 million today to possibly 15 million in 2050, the healthcare system will rely on those caregivers even more. It is well established that family caregiving is taxing and stressful and that managing the day-to-day life of PLWD and handling the behavioral and psychological symptoms in dementia (BPSD) that they may exhibit are the main sources of stress. Group-based psychoeducational programs such as the Savvy Caregiver program (SCP) have demonstrated that the acquisition of skills, knowledge, and caregiving mastery can ameliorate caregiving stress - and enhance PLWD quality of life. Many factors, however, preclude caregivers' attendance in group-based programs and limit programs' scalability. To address the issue of access, the researchers have developed the Tele-Savvy program, an online version of SCP that brings groups of caregivers together in facilitator-led synchronous groups and provides substantive educational augmentation through asynchronous e-mail-delivered video lessons. The first aim of this study is to develop a fully asynchronous online Savvy program that incorporates learning activities that promote both knowledge and skill acquisition and develop and enhance caregivers' felt-sense of caregiving mastery. Developing this education program will utilize input from clinicians, educators, Tele-Savvy facilitators, and caregiver advisors. The second study aim is to determine the feasibility, acceptability and preliminary efficacy of the created online program. This study will recruit 60 family caregivers to take part in a no-control trial of the program. Data will be gathered at baseline, immediately upon course completion and at 3 months post-baseline to assess caregiver distress measures (depression, strain, burden, anxiety), caregiver competence/ mastery, and care recipient quality of life.

Interventions

BEHAVIORALFully Asynchronous Online Savvy Program

The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days. Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including: * Facts about dementing Illnesses * Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible * Self-Care for the Caregiver

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* primary unpaid caregiver for a community-dwelling PLWD * provide at least 10 hours of direct care per week * able to read and understand English * be able to access the course online * naïve to Savvy or Tele-Savvy

Exclusion criteria

* cannot provide consent * prisoners * cognitively impaired adult * not able to clearly understand English

Design outcomes

Primary

Measure	Time frame	Description
Center for Epidemiologic Studies - Depression (CES-D) Score	Baseline, Month 2, Month 3	The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely = 0 and most of the time = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Zarit Burden Interview Score	Baseline, Month 2, Month 3	The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
State-Trait Anxiety Inventory (STAI) Score	Baseline, Month 2, Month 3	The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Caregiver Mastery Scale - Caregiving Competence Score	Baseline, Month 2, Month 3	The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where not at all = 1 and completely or very = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score	Baseline, Month 2, Month 3	The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score	Baseline, Month 2, Month 3	The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.

Countries

United States

Participant flow

Recruitment details

Participants were recruited in Atlanta, USA. Participant enrollment began September 15, 2021 and all follow-up assessments were completed by September 2, 2022.

Participants by arm

Arm	Count
Fully Asynchronous Online Savvy Program Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.	60
Total	60

Arm

Count

Fully Asynchronous Online Savvy Program

Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Completed study assessments but did not complete the intervention	10
Overall Study	Lost to Follow-up	16
Overall Study	Withdrawal by Subject	5

Baseline characteristics

Characteristic	Fully Asynchronous Online Savvy Program
Age, Continuous	58.217 years STANDARD_DEVIATION 14.438
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) White	48 Participants
Region of Enrollment United States	60 Participants
Sex/Gender, Customized Female	50 Participants
Sex/Gender, Customized Male	9 Participants
Sex/Gender, Customized Non-binary	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 60
other Total, other adverse events	0 / 60
serious Total, serious adverse events	0 / 60

Outcome results

Primary

Caregiver Mastery Scale - Caregiving Competence Score

The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where not at all = 1 and completely or very = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.