PrepAD Study (Prepare for Alzheimer Dementia). An evaluation of the feasibility of an online self-management program for spousal caregivers of patients with (very) early-stage dementia including prodromal dementia (Mild Cognitive Impairment due to AD)

PrepAD Study (Prepare for Alzheimer Dementia). An evaluation of the feasibility of an online self-management program for spousal caregivers of patients with (very) early-stage dementia including prodromal dementia (Mild Cognitive Impairment due to AD) - PrepAD Study (Prepare for Alzheimer Dementia)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38692

Enrollment

Registered

2013-08-19

Start date

2013-09-09

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

geen aandoeningen, ervaren controle en zelfvertrouwen en psychische belasting/stress bij partners van mensen met MCI (milde geheugenproblemen) en dementie in een vroeg stadium Caregiver self-efficacy and perceived control + burden/stress in partners of MCI/early-stage dementia patients

Interventions

Participants will be asked to participate in an online self-management program called *Partner in Balans* over an 8-week period. In addition, they will meet twice with a personal coach to assess goa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Spousal caregiver of a patient diagnosed with (very) early-stage dementia including prodromal dementia (MCI due to AD, according to the clinical criteria established by McKhann (1984; 2011)). - Caregiver and patient share a household. - Caregiver has access to the Internet at home and already has some experience with the use of computers. - Written informed consent is obtained.

Exclusion criteria

Exclusion criteria: - Caregivers who have insufficient cognitive abilities to engage in the online self-management program (based on clinical judgment of knowledgeable practitioner). - Caregivers who are overburdened or have severe health problems (based on clinical judgment of knowledgeable practitioner). - Caregivers of people with dementia caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea of Huntington or alcohol abuse

Design outcomes

Primary

Measure	Time frame
Feasibility of the online self-management intervention: To evaluate the feasibility of the online program and the satisfaction with the online program, we based our procedure on different studies that execute comparable work (e.g. (Teel and Leenerts 2005) and suggestions made by Conn et al. (Conn, Algase et al. 2010) how to conduct pilot intervention work. First of all, we will conduct a 30-item, investigator-developed semi-structured questionnaire to evaluate the feasibility of the program based on the measurement scales for perceived usefulness and perceived ease of use and user acceptance of information technology (Davis 1989) and previously used scales by Teel and Leenerts (2005). Feasibility questions include subjective participants ratings of the session format and time burden, communication method, intent to use session information, time spent on the program, which parts of the program were most and least helpful, factors that facilitated and interfered with understanding the self-care information, how they perceived the role and presence of the personal coach, the overall acceptability of the intervention and any suggestions for change. Items can be rated on a 7-point scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Average item scores of 5 and higher will be considered as acceptable feasibility with minor revisions of the program. Scores of 4 and lower will be considered as unacceptable feasibility with major revisions of the program. For further details on the cut-off scores of the item total on the questionnaire, see paragraph 5.2.2 Instruments. To provide insights about revisions that may be needed to offer a more effective of efficient intervention in the upcoming study, participants will be asked to elucidate their score by asking questions like In what way was the coach (not) helpful in this program? Why did you visit/skip certain aspects of the program? Why were they (not) helpful etc. In addition, by	—

Measure

Time frame

Feasibility of the online self-management intervention: To evaluate the feasibility of the online program and the satisfaction with the online program, we based our procedure on different studies that execute comparable work (e.g. (Teel and Leenerts 2005) and suggestions made by Conn et al. (Conn, Algase et al. 2010) how to conduct pilot intervention work. First of all, we will conduct a 30-item, investigator-developed semi-structured questionnaire to evaluate the feasibility of the program based on the measurement scales for perceived usefulness and perceived ease of use and user acceptance of information technology (Davis 1989) and previously used scales by Teel and Leenerts (2005). Feasibility questions include subjective participants ratings of the session format and time burden, communication method, intent to use session information, time spent on the program, which parts of the program were most and least helpful, factors that facilitated and interfered with understanding the self-care information, how they perceived the role and presence of the personal coach, the overall acceptability of the intervention and any suggestions for change. Items can be rated on a 7-point scale, ranging from 1 (*strongly disagree*) to 7 (*strongly agree*). Average item scores of 5 and higher will be considered as acceptable feasibility with minor revisions of the program. Scores of 4 and lower will be considered as unacceptable feasibility with major revisions of the program. For further details on the cut-off scores of the item total on the questionnaire, see paragraph 5.2.2 Instruments. To provide insights about revisions that may be needed to offer a more effective of efficient intervention in the upcoming study, participants will be asked to elucidate their score by asking questions like *In what way was the coach (not) helpful in this program?* *Why did you visit/skip certain aspects of the program? Why were they (not) helpful* etc. In addition, by

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Secondary

Measure	Time frame
Rating the difficulty and time burden of completing the pre- and post-intervention conducted questionnaires (see paragraph 5.2.2 Instruments) with a feasibility questionnaire on conduction of the questionnaires will assess the feasibility of the research protocol for the upcoming randomized controlled trial. The separate items can be rated on a 7-point scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Average item scores of 4 and lower will be considered as acceptable feasibility of the questionnaires with minor revisions of the research protocol. Scores of 5 and higher will be considered as unacceptable feasibility of the questionnaires with major revisions of the research protocol. For further details on the cut-off scores of the combined items, see paragraph 5.2.2 Instruments.	—

Measure

Time frame

Rating the difficulty and time burden of completing the pre- and post-intervention conducted questionnaires (see paragraph 5.2.2 Instruments) with a feasibility questionnaire on conduction of the questionnaires will assess the feasibility of the research protocol for the upcoming randomized controlled trial. The separate items can be rated on a 7-point scale, ranging from 1 (*strongly disagree*) to 7 (*strongly agree*). Average item scores of 4 and lower will be considered as acceptable feasibility of the questionnaires with minor revisions of the research protocol. Scores of 5 and higher will be considered as unacceptable feasibility of the questionnaires with major revisions of the research protocol. For further details on the cut-off scores of the combined items, see paragraph 5.2.2 Instruments.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)