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PrepAD Study: Prepare For Alzheimer Dementia - Feasibility of an online course to strengthen spouses of people with (very) mild dementia, including prodromal dementia (Mild Cognitive Impairment due to AD)


- candidate number15586
- NTR NumberNTR4217
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2013
- Secondary IDsNL44475.068.13 L.M.M. Boots
- Public TitlePrepAD Study: Prepare For Alzheimer Dementia - Feasibility of an online course to strengthen spouses of people with (very) mild dementia, including prodromal dementia (Mild Cognitive Impairment due to AD)
- Scientific TitlePrepAD 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)
- ACRONYMPrepAD
- hypothesisThe objective of this pilot study is to evaluate the feasibility of and the satisfaction with a newly developed online self-management program for spousal caregivers of patients with (very) early-stage dementia including prodromal dementia (MCI due to AD). In addition, the feasibility of the research protocol will be assessed, in preparation for the upcoming randomized controlled trial.
- Healt Condition(s) or Problem(s) studiedIntervention, Online Prevention, Informal care-givers, Dementia, MCI Mild Cognitive Impairment
- 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)
- Caregiver and a 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- 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 (base don 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 9-sep-2013
- planned closingdate9-mrt-2014
- Target number of participants10
- InterventionsParticipants 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. The online program will make use of a self-management program, aimed at learning skills and taking the personal needs of the caregivers as starting point. Online self-management programs have already been used to support patients and caregivers and show promising results. The Stress and Coping model by Lazarus and Folkman (1984) and the Social Learning theory by Bandura (1977) also served as the theoretical framework for the development and evaluation of the program. In addition, the program was based on the knowledge and experience of the target group (by means of focus group interviews) and professionals (individual interviews) who deal with MCI/dementia caregivers on a daily basis.
- Primary outcomeFeasibility 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 program participation 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”). 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 means of the system data (objective measures of time spent on the program), we can assess dose integrity by tracking the number and duration of intervention sessions and evaluate if the actual time spent per module corresponds with the intended time spent per module. If major differences appear we will evaluate the reason for this difference and the impact of these differences on the feasibility of the program with the responses on the feasibility questionnaire. Furthermore, dropout will be evaluated.
- Secondary outcomeRating the difficulty and time burden of completing the pre- and post-intervention conducted questionnaires with the 2-item conduction of questionnaires survey 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”).
- TimepointsPrimary outcome: 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. Drop-out: Based on the criteria of the Cochrane Back Review Group (van Tulder, Assendelft et al. 1997), a maximum percentage of 20 for short-term follow-up and 30 for long-term follow-up is considered as an acceptable dropout rate. Taking the reasons for dropout into account, we will use these criteria as an additional measure of the feasibility of the online program. Secondary outcome: 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.
- Trial web sitewww.partnerinbalans.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lizzy Boots
- CONTACT for SCIENTIFIC QUERIES Lizzy Boots
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD21-okt-2013 - 2-dec-2013


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