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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptHHS Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
J Neurosci Nurs. Author manuscript; available in PMC 2012 December 1.
Published in final edited form as:
PMCID: PMC3220889

Content Validity and Acceptability of the Daily Enhancement of Meaningful Activity Program Intervention for Mild Cognitive Impairment Patient-Spouse Dyads

Yvonne Yueh-Feng Lu, PhD, RN and Joan E. Haase, PhD, RN, FAAN


Persons with mild cognitive Impairment (PwMCI) are at greater risk for developing Alzheimer’s disease and they experience various difficulties that decrease their quality of life. Very few interventions focus on helping PwMCI improve or maintain functional performance and enhance quality of life through meaningful activity engagement. The purpose of the study was to explore PwMCI and their spouses’ perspectives on the content validity, usefulness, and acceptability of the daily enhancement of meaningful activity (DEMA) program, which included 6 bi-weekly face-to-face sessions, between session assignments, and a self-management tool kit of written educational handouts. Nine PwMCI-care partner dyads participated in three focus groups (PwMCI alone, spouses alone, couples) to capture their perspectives on DEMA. The transcribed focus group data were analyzed through content analysis. The three groups provided support for content validity and acceptability of the program, and they suggested additional content areas important to couples experiencing MCI. They also attested to the usefulness of the tool kit and gave suggestions for its further improvement. The findings provide evidence of the content validity and acceptability of the DEMA program. A pilot study to assess feasibility and preliminary efficacy of the DEMA on health-related outcomes is the recommended next research step for this program.

Keywords: patient care partner, mild cognitive impairment, acceptability of program, program evaluation


Mild cognitive impairment (MCI) is one of the most prevalent age-related disorders, affecting one fifth of the elderly population. Persons with MCI (PwMCI) are at increased risk for developing Alzheimer’s disease (AD) (Busse, Bischkopf, Riedel-Heller, & Angermeyer, 2003; Unverzagt et al., 2007). Community- and population-based studies indicate that MCI progresses to dementia at a very high rate, from 13–48% over 12–60 months (Bennett, Schneider, Bienias, Evans, & Wilson, 2005; Busse, et al., 2003; Prencipe et al., 2003; Unverzagt et al., 2001)

Although PwMCI do not have full-blown dementia and do not experience the same level of difficulty, they do experience many difficulties that decrease their quality of life, including significant conflict in their relationships, depressed mood, decreased engagement in daily activities, and reduced ability to engage in complex daily activities (Apostolova & Cummings, 2008; Perneczky, Pohl, Sorg, Hartmann, Tosic, et al., 2006). PwMCI may be unaware of their deficits such as financial management or driving skills that place themselves at risk and also cause stress and conflict with their family members. In addition, family caregivers may inaccurately judge the MCI patient’s function or awareness of performance capacity’s (Clare, 2004; Laurin, Verreault, Lindsay, MacPherson, & Rockwood, 2001; Okonkwo et al., 2009; Wadley et al., 2009). This misunderstanding can contribute to increased conflict in the relationship and contribute. It may also result in a decline in the MCI patient’s quality of life because the patient realizes that his family believes him or her to be incapable. Spouses of PwMCI also experience quality-of-life problems, including relational deprivation, communication difficulty, and emotional distress associated with the cognitive deficits of patients (Austrom & Lu, 2009; Garand, Dew, Urda, Lingler, DeKosky, & Reynolds, 2007; Lu, Hasse, & Farran., 2007). Findings from a systematic review of literature indicate that cognitive training interventions are increasingly available (Jean, Bergeron, Thivierge, & Simard, 2010), most of which focus on the performance of memory tests, driving capability (Edwards et al., 2009) and psychological well-being (Apostolova & Cummings, 2008; Belleville, 2008; Bolleville et al., 2006; Kinsella et al., 2009; Troyer, Murphy, Anderson, Moscoritch, & Craik, 2008). One large randomize trial study showed that cognitive training, speed process of training, improves cognitive ability and less functional decline in instrument daily activities in well-functioning older adults (Willis et al., 2006). Even with progressive memory loss, interventions that are delivered early can assist PwMCI to communicate effectively with their spouses, and deal with memory loss problems affecting their activities of daily living. Such interventions have the potential of fostering physical and psychosocial well-being, prolonging functional independence, and decreasing costs (Jack et al., 2011). Though behavioral intervention have been evaluated for patients with dementia (Podewils, Guallar, Kuller, Fried, Lopez, Carlson, et al., 2005; Tappen, Roach, Applegate, & Stowell, 2000; Teri et al., 2003; Vance, Moore, Farr, & Struzick, 2008), very few interventions focus on helping PwMCI improve or maintain functional performance or enhance quality of life through meaningful activity engagement and few have specifically targeted the intertwined needs of the patient-caregiver dyad.

Daily meaningful activities are defined as activities that an individual finds important and enjoyable, ranging from the simple satisfaction derived from small daily rituals to the intense pleasure people feel in pursuing their driving passions (Kielhofner, 2002). These meaningful daily activities may include physical, cognitive, social, and leisure activities (Jedrziewski, Lee, & Trojanowski, 2007; Larson et al., 2006; Verghese et al., 2006). PwMCI and their family members experience significant challenges in coping with problems, adjusting to changes, and planning for the future (Garand, Dew, Eazor, DeKosky, & Reynolds, 2005; Garand, et al., 2007; Lu et al., 2007; Lu & Haase, 2009). Since PwMCI desire to preserve their ability to perform daily meaningful activities(Lu et al., 2007), have greater awareness of their limitations, and possess greater learning ability than patients with Alzheimer’s Disease (Roberts, Clare, & Wood, 2009), earlier stages of cognitive decline offer an important window of opportunity to provide behavioral interventions to develop important self-management skills that will prevent premature disability and disengagement. Tailored interventions delivered to PMCI-family member (e.g., care partner) dyads at the earliest stage of cognitive impairment might have potential for being effective.

In this paper the authors describe the evaluation of the Daily Enhancement of Meaningful Activity (DEMA) intervention by 3 focus groups: PwMCI only, care partner only, and couples, (i.e., PwMCI and spouses combined). The purpose of the study was to explore the participants’ perspectives on the content validity, usefulness, acceptability, and feasibility of the DEMA written educational materials, the DEMA program, and the program delivery format. The focus groups not only contributed to the refinement of the DEMA program and educational written materials; they also provided insights into the kind of help that PwMCI and their spouses need and want and the degree to which intervention components and design features are seen as helpful, acceptable, and feasible by PwMCI and their spouses.

Description of DEMA

DEMA was designed as a tailored skill-training program that aims to help couples facing MCI learn ways to supportively work together to meet goals and learn ways to adapt to changes that might occur over time. Content for DEMA was derived from several sources: 1) the Occupational Performance Model (Kielhofner, 2002) and problem solving therapy (Barrett et al., 1999) for content regarding identifying and planning meaningful activities; 2) literature review (Department of Health and Human Service, 2010; Lehmann, Regland, Blennow, & Gottfries, 2003; Mann et al., 2004; Mayo Clinic, 2008; U.S.; Okonkwo, Waldley, Griffith, Ball, & Marson, 2006; Perneczky et al., 2006; Petersen, 2007; Petersen et al., 2001; Podewils et al., 2005; Rejeski et al., 2009; Rosenberg, Kottorp, Winblad, & Nygard, 2009; Rovner, Casten, Leiby, & Tasman, 2009) and the American Alzheimer Association website for content on MCI diagnosis, symptoms, and treatments (Alzheimer Association, 2009); and 3) a qualitative study of MCI couples’ experiences of living with MCI for content on emotional responses to MCI and guidelines for dealing with/living with MCI as a couple (Lu & Haase, 2009; Lu et al., 2007). Prior to obtaining perspectives of DEMA from focus group participants, the intervention was evaluated and refined based on feedback related to content validity, face validity, feasibility, and acceptability from an expert panel of six scientists/clinicians (expertise in neurology, geriatric medicine, geriatric nursing, health behavior)as was as, from and three other experts (the director of the local Alzheimer’s Association, a medical visual media designer, and an experienced format designer) feedback.

The outcome of the expert panels was a DEMA intervention designed for delivery in 6 bi-weekly, one-hour, face-to-face sessions respectively focusing on 6 self-management needs: 1) planning meaningful activity, 2) understanding MCI, 3) understanding the treatment of mild cognitive impairment, 4) understanding and dealing with negative emotional responses, 5) learning strategies for living with MCI and dealing with major concerns, and 6) finding available local and national resources. The 6 sessions were planned for delivery by an advanced practice nurse intervener. Content for Session 1 focused on introducing the couple to the intervention and meaningful activity concepts, reviewing the PwMCI’s history of meaningful activity, establishing a realistic and manageable meaningful activity plan, and introducing the 6 areas for counseling topics. The couple then set goals and developed a plan for activities that they considered important and meaningful; during the two weeks between sessions, participants worked on the agreed-upon goals and activities, either as a couple, as the PwMCI, or as the care partner. In Sessions 2 to 6, the first 30–40 minutes focused on the specific meaningful activity that had been planned during the previous session and included: a) assessing any concerns that might have occurred related to the planned activity engagement; b) reviewing the nature and frequency of existing meaningful activity patterns; c) using problem-solving to assess the current week’s activity plan and making any necessary modifications; d) identifying ways of maintaining meaningful activity engagement. Guided by the Self-management Tool Kit, the last 20–30 minutes focused on 1 of the 6 counseling topics (see Table 1). The tool kit is organized around the 6 self-management needs, and consists of 40 subtopic handouts. For each session, between 5 and 8 subtopic handouts were available to the couple to help structure the face-to-face sessions (see Table 2).

Table 1
Daily Enhancement of Meaningful Activity (DEMA) Program Content
Table 2
Self-management Tool Kit


Three focus groups were conducted to capture, respectively, the perspectives of the PwMCI, spouses, and couples on DEMA. Specifically, the focus groups assisted in evaluation of the content validity and acceptability of the Self-management Tool Kit, the DEMA intervention content, the intervention format, and the barriers to using the program among PwMCI and their spouses.

Sample and Setting

A convenience sample was obtained through clinics associated within the Indiana University (IU) Health Care System, specifically the University Hospital neurology clinics, the IU Alzheimer Center, and the IU Healthy Aging Brain Center. To be enrolled in the study, both the PwMCI and the care partner had to consent. In each setting, participants were first approached by the professional staff to ascertain interest in participating. Focus group participants were those PwMCI who had been officially diagnosed at least 6 months prior to study enrollment and their care partner. Inclusion criteria required persons with MCI to be English-speaking adults, aged 60 or older, who had a medical diagnosis of MCI for at least 6 months. The diagnosis of MCI was made on the basis of clinical examination by the geriatric neurologist and/or neuropsychologist, using criteria consistent with the guidelines established by Petersen and colleagues (Petersen et al., 1999). Inclusion criteria of care partners required that they be English-speaking adults, identified by the PwMCI as their primary care partner. All the care partners identified by the PwMCI were spouses. Of the 20 couples identified, 6 did not meet the recruitment criteria. Of the remaining 14 couples, 5 (35.71%) declined participation and 9 (64.29%) consented to participate and were enrolled in the focus groups. The reasons for choosing not to participate were: either the PwMCI or spouse (but never both) was not interested (n = 3), scheduling conflicted with spouse’s work (n= 1), and driving distance to attend the focus group was too far (n = 1).

Participant Characteristics

The accrued PwMCI sample (n = 9) included 7 males and 2 females, who were all Caucasian and retired. Their mean age was 68.9 years (SD = 8.4), mean education was 16.9 years (SD = 2.47), and time since diagnosis was 1.5 to 4.5 years (M = 2.8 years). The accrued spouse sample (n = 9) included 8 Caucasians (6 females, 2 males) and 1 female Asian American. Two of the PwMCI had received depression medication treatment for at least one month. The spouses’ mean age was 65.1 (SD = .97) years and the mean education was 15.3 (SD = 7.5) years. Eight of the 9 couples were in their first marriage; one couple was in a second marriage. All reported their financial status as adequate to meet their needs; however, 1 of the 9 couples was concerned about their future financial status because of the economic recession in the U.S. Before retirement the PwMCI had primarily worked in the professional or business sector (engineer, manager, university professor, financial consultant, high school teacher, or secretary). Most spouses were retired and not working; one spouse was working in a full-time manager position, and two were working part-time as a secretary or in business.

Data Collection Procedure

In this IRB-approved study, the 9 couples who indicated interest in participating were contacted and given a more detailed description of the study. The signed consent forms were collected by mail at least one week prior to the focus group meeting or in person before the focus group meeting. For those couples who returned signed consent forms or had verbally agreed to participate, the meeting time and location were mailed along with a cover letter, a brief description of the program, and a copy of the most recent version of the Self-management Tool Kit at least one week prior to the focus group meeting. Couples were asked to read the program brief description and tool kit materials and to make notes about them as reminders of comments or questions they wished to raise during the focus group meetings.

The first round of focus group meetings was done simultaneously and separately for PwMCI (n = 6) and the spouses (n = 6). Each group was led by a certified focus group facilitator with a master’s degree in social work. During the meetings, the facilitators solicited comments regarding relevance, clarity, and appropriateness of the content of the Self-management Tool Kit and acceptability of intervention implementation, including the length, timing, and mode of delivery. The third focus group (3 couples) was held after revisions were made to DEMA based on feedback from the initial 2 groups. In this second round, three PwMCI-spouse dyads met with a certified focus group facilitator.

Data-generating Questions

To guide discussion and evaluate the content of the Self-management Tool Kit and DEMA program with the first two groups, we used a list of open-ended questions, with follow-up questions as needed. The questions were as follows. (1) In general, what do you think about the written material? (2) For each session, is there anything we should add or delete? (3) Regarding the written material, what was the most helpful information for you? (4) What was least helpful for you? (5) How relevant, clear, and appropriate is the material? (6) Are there any aspects of your life that have been affected by memory problems that are not covered? (8) Is there anything else you would like to let us know? (8) Do you think you could benefit from this program? Additional questions were asked regarding couples’ preferences related to implementing the program, including recruitment strategies; location, schedule, duration and frequency of intervention; and preferences for individual, small group, telephone, or online delivery method.

The list of open-ended questions for the third focus group, was the same as for the first two. Additionally, this group was asked to provide more detailed information on the usefulness and acceptability of program implementation. The third focus group was also asked to provide comments on the content of the Self-management Tool Kit based on the revisions from the initial 2 groups. At the end of all focus groups meetings, participants were asked to return their written comments (if any) to the investigators.


The transcribed focus group data were analyzed by two nurse scientists using content analysis methods (Miles & Huberman, 1994). The significant statements were identified from data obtained from each focus group and initially categorized by using a predetermined start list addressing the acceptability domains (e.g., most helpful and least helpful content, comprehensibility and adequacy of content, acceptability of the intervention format [length and duration of program, frequency of meeting sessions, meeting location, and schedule]). The significant statements were organized into theme categories. The researchers also compared the congruence and differences in coding of significant statement data across the three focus groups. The researchers discussed differences in the coding of significant statements until 100% agreement was reached. The resulting categories were used to narratively describe findings. Seven sub-themes were developed: What the couple wants in the intervention; self-management; communication skills; technology needs; emotional management; program implication; and recruitment strategy.


The following is a summary of the findings related to face validity and acceptability of DEMA. Participants’ views were solicited about the Tool kits, intervention format, content evaluation, and recommendations for improving the intervention protocol and Tool Kit.

Focus Group Comments

Overall, participants’ perceived the content as adequate, clear, and easy to follow and understand. The ordering of the sessions was deemed appropriate by the couples. Couples indicated that Session 1, planning daily meaningful activity, helped them to positively focus on individual strengths, health promotion, and remaining “hopeful” rather than focusing on deficits. Couples also agreed that having session objectives raised their level of interest in and attention to the main topics of the session.

All groups provided insightful comments on the tool kit components and specified the most helpful tool kit components and mechanisms. For example, the all 3 groups indicated that the handout on examples of meaningful activities was very helpful because it not only reinforced meaningful activities they had done before; use of the weekly plan also guided them to again initiate these and other activities in practical and manageable ways. The PwMCI and spousal groups agreed that the topic of negative emotional responses helped them better deal with such responses. The handout on living with MCI was helpful for PwMCI to manage their challenges, and the spousal group indicated it would be a useful tool to open discussion with PwMCI and other family members. Notably, the handout on resources regarding medications and finding a good attorney was highly accepted by the spousal group, although it was not mentioned by either the PwMCI or the couple group. The advantage of having the three types of focus groups is that the results showed there were some topics (e.g., finding a good attorney) the spouses probably did not want to discuss in front of the patients.

Each group offered explicit comments on the intervention format and content-sensitive issues. The spousal group had several suggestions, including: eliminating all abbreviations on written materials; providing brief and clear definitions of medical terms; using a large font size; and keeping content simple and easy to understand. The Self-management Tool Kit was designed for both PwMCI and their spouse to use together, but spouses preferred to have their own tool kit with more advanced information. In addition, the couples preferred to attend the program together in order to gain understanding and improve communication with each other. The PwMCI and couple groups emphasized the importance of including clear objectives for each session, because this helped them understand and stay focus on each session. Interestingly, the spouse and couple groups made several comments and suggested modifications regarding content sensitivity, but the PwMCI group did not focused these issues. For example, spouses of PwMCI disliked being called “caregiver” and preferred being called “husband/wife,” “care partner,” or “supporter” because they viewed themselves in these ways. The spouses also raised gender sensitivity issues related to types of housework, such as that cleaning and laundry are not men’s works. They also disliked certain terms of emotional distress such as “grief” and “isolation,” and they suggested alternate terms such as “feeling sorrow” and “being alone.”

Table 3 contains a summary of the four main areas that participants thought should be included in the program: self-management, communication skills, technology needs, and emotional management. The groups recommended establishing useful self-management tips, such as how to organize household items to help PwMCI perform their activities independently. Improving communication skills was also one of the participants’ primary needs. For example, PwMCI wanted to learn ways to tell their spouse not to overprotect them, and spouses wanted tips on telling other family members or close friends about their memory problems and how to encourage PwMCI to stop potential harmful activity such as using an electric saw for cutting trees. It is interesting to notice that managing emotional distress and training in the use of technology-assisted devices training were raised by the PwMCI and spouse groups. For example, they agreed that depression was a common occurrence that should be addressed. The PwMCI also recommended providing information and training, as well as specific modification, on technology-assisted devices, especially Global Positioning Systems (GPS) and mobile phones.

Table 3
What Couples Want In Intervention: Content Recommendations by Focus Group.

Table 3 also shows the comments on the program format, such as program dosage, schedule, meeting location, and delivery. The program dosage plan, which included bi-weekly meetings for a total of 6 sessions with 1 hour for each session, was acceptable to all three focus groups, except several working spouses who did not have a regular working schedule. Additionally, the spousal and couples groups recommended the following: (a) flexibility with scheduling; (b) a delivery site at the clinic or participant’s home; and (c) meeting on weekday mornings, but late enough to avoid rush hour driving. Having program delivery in small groups was suggested by the spousal group, thought not by PwMCI. Both PwMCI and spouses agreed that the best recruitment strategy was physicians’ referral, but other strategies could be considered such as advertisements in local newspapers, TV, or radio. Finally, the main reasons for research participation were: to make a “contribution” for other PwMCI and their family members, to gain knowledge about MCI and its treatment, and to learn coping and caregiving skills.


It was important to establish evidence of the content validity and acceptability of this newly developed intervention from both the PwMCI and spouses’ perspectives. The three focus groups (PwMCI, spouses, and couples) provided important comments and specific recommendations on the revision of the DEMA program format and the content of the Self-management Tool Kit. The focus group participants not only provided support for content validity and acceptability of the DEMA program; they also recommended additional content areas important to couples experiencing MCI such as having positive experiences of using GPS to minimize incorrect driving directions and arguments while the PwMCI was driving. The PwMCI focus group believed it would be useful to provide information and training on technology-assisted devices, and they gave specific suggestions for improvement of the handouts in this area.

Consistent with past research (Farias et al., 2006; McIlvane, Popa, Robinson, Houseweart, & Haley, 2008), PwMCI recognized that they needed help with executive functioning-related activities such as taking phone messages and organizing medication, The did not feel the need for help with basic daily living activities, since they were able to select their own clothing, bathe themselves, feed themselves, and walk around the neighborhood. In addition, similar to other descriptive studies, the authors found that PwMCI perceived greater difficulty in using technology than healthy older adults (Rosenberg, et al., 2009) and wanted brief training from locally available resources in order to use technology devices (e.g., GPS or mobile phone). Since they considered mobile phones to be quite useful, offering advice on models with larger button and display sizes, and providing simplified manuals should be considered for future study (Mann, et al., 2004).

Similar to previous studies, PwMCI and their spouses showed a great deal of interest in health promotion activities (engaging in meaningful activities or brain exercises) for preserving independent functioning or decreasing the limitations associated with the progress of memory problems (McIlvane, et al., 2008). Although changes in the underlying functional impairment are difficult to achieve, the impact of impairment in daily activity or meaningful activity engagement may be mediated by training in compensatory strategies.

Even though the spousal group did not currently feel the need for help to use local or national resources for activities such as home repair/maintenance, adult day services, or home-delivered meals, they thought they might need such resources in the future. The degree to which both the PwMCI and the spouse groups indicated the desire and need for knowledge about GPS was interesting. A previous study suggested that global positioning system (GPS) technology may be able to provide further information about driving patterns among older adults (Marshall et al., 2007).

Since PwMCI are eager to learn new skills and could be taught how to use strategies to adjust activities and to manage emotional distress such as depression that might be associated with MCI (Troyer, et al., 2008), they might be able to apply problem-solving therapy skills to overcome these challenges. Current clinical trial studies have shown that problem-solving therapy is effective in reducing emotional distress and depression among older adults with MCI (Kiosses, rean, Teri, & Alexopoulos, 2010). In addition, consideration should be given to providing training on GPS and cell phones to maintain or improve functioning performance.

The focus group showed that spouses had needs for information and for acquiring skills to improve communication and manage emotional distress, suggesting that it is important to provide early intervention to assist PwMCI and/or family members to gain self-management skills that could influence PwMCI behavior (de Vugt et al., 2004). The findings also support the importance of integrating family members into interventions designed for PwMCI, because it provides a foundation of support as family members move to a greater caregiving role in response to the progression to Alzheimer’s disease, which was also reported by Brodaty et al (Brodaty, Green, & Koschera, 2003).

Recruitment Issues

Like the other community studies for older adults (Blumenthal, Coates, Williams, & Liff, 1995; Cohen-Mansfield, 2002), the recruitment of PwMCI-family member dyads and minorities for the focus groups was a challenge, especially when the study offered no immediate therapeutic benefit. Similar to other studies, the most common reasons for refusal to participate were: not interested (or denying having memory problems) and conflict with spouse‘s work schedule (Dilworth-Anderson, Thaker, & Detry Burke, 2005; Shatenstein, Kergoat, & Reid, 2008). The DEMA might not be useful to those unwilling to admit any problems, because the DEMA depends on being willing to acknowledge and discuss problems. Since the pilot study relied on referrals and on the match between the referral and the inclusion criteria, relaxing some exclusion criteria could be considered in order to improve recruitment in the future (e.g., being able to recruit non-spouse adult family members and unpaid caregivers).


Generalizability of the findings from this study is limited due to having a small sample size that lacked minority participants. Although the sample size was small, it was adequate for examining content validity and acceptability of a new intervention for non-minority participants (Arnold et al., 2009; Lancaster, Dodd, & Williamson, 2004). In addition, only spouses were included; adult children who are care partners may have different perspectives. The authors recommend that further research be conducted on the efficacy of DEMA using larger and more diverse samples.


Establishing evidence of the content validity and acceptability for a new intervention is very important before conducting large clinical trials to evaluate efficacy. The findings of this study provide preliminary evidence of the content validity and acceptability of the DEMA program. Future research is needed to test the feasibility and effectiveness of the DEMA on health-related outcomes with a larger sample that compares the intervention group to a control group. If the DEMA program is shown to be valid and effective, testing the effectiveness of a telephone-based or web-based DEMA program should also be considered, to potentially reach a broader and more diverse population of PwMCI and their family members, to improve their emotional well-being, maintain/improve functioning, and improve quality of life.


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